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Movement Disorder Clinical Trials

MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)

NCT ID: NCT01028586

Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, extension trial, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation.

Condition:

Eligibility:

Inclusion Criteria: 1. The subject completed 24 weeks of Trial 27918. 2. The subject successfully completed all trial requirements in Trial 27918. 3. If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive". 4. Subject is willing and able to participate in the trial and has provided written, informed consent Exclusion Criteria: 1. If female, the subject is pregnant or lactating. 2. The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion. 3. The subject has shown clinically significant deterioration during participation in Trial 27918. 4. Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication. 5. The investigator deems it is not in the subject's best interest to participate to trial 27938 6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.

Gender: Both
Minimum Age: 30 Years
Maximum Age: 80 Years
Healthy Volunteers: No

Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

NCT ID: NCT00865579

Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in humans. Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.

Condition:

Eligibility:

Inclusion Criteria: 1. the subject has completed a previous clinical study with Safinamide in PD 2. the subject successfully completed all trial requirements of the antecedent trial 3. if female, they must be either post-menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential, they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial women of child bearing potential are defined of all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive 4. subjects must be willing and able to participate in the trial and provide written informed consent Exclusion Criteria: 1. the subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with Safinamide 2. if female, the subject is pregnant or lactating 3. any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject's ability to participate in this open-label trial

Gender: Both
Minimum Age: 30 Years
Maximum Age: N/A
Healthy Volunteers: No

Coenzyme Q10 in Huntington's Disease (HD)

NCT ID: NCT00608881
Principal Investigator: Merit Cudkowicz, MD MSc

The goals of this trial are to determine if coenzyme Q10 is effective in slowing the worsening symptoms of Huntington's disease and to learn about the safety and acceptability of long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.

Condition:

Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available. The purpose of this trial is to find out if coenzyme Q10 (CoQ) is effective in slowing the worsening symptoms of HD. In this study, researchers also will learn about the safety and acceptability of long-term CoQ use by determining its effects on people with HD. Participants in this trial will be randomly chosen to one of two groups. Group 1 will receive CoQ (2400 mg/day), and group 2 will receive a placebo (an inactive substance). Researchers will compare the change in total functional capacity (TFC)—a measure of functional disability—in the two groups. The TFC is a valid and reliable measure of disease progression and is particularly responsive to change in the early and mid-stages of HD. Researchers will also compare the changes in other components of the Unified Huntington's Disease Rating Scale '99 (UHDRS) including: the total motor score, total behavioral frequency score, total behavior frequency X severity score, verbal fluency test, symbol digit modalities test, Stroop, interference test, functional checklist, and independence scale scores. The groups will also be compared with respect to tolerability, adverse events, vital signs, and laboratory test results as measures of safety.

Eligibility:

Inclusion Criteria: To be eligible for enrollment into this study, subjects must meet the following eligibility criteria within 28 days prior to randomization: - Subjects must have clinical features of HD and a confirmed family history of HD, OR a CAG repeat expansion ≥ 36. - TFC > 9. - Must be ambulatory and not require skilled nursing care. - Age ≥ 16 years. - Women must not be able to become pregnant (e.g., post menopausal, surgically sterile or using adequate birth control methods for the duration of the study). - If psychotropic medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants), they must be at a stable dosage for four weeks prior to randomization and should be maintained at a constant dosage throughout the study, as possible. (Note: stable dosing of tetrabenazine is allowable.) Any changes to these medications mandated by clinical conditions will be systematically recorded and the subject will be permitted to remain in the trial. - Able to give informed consent and comply with trial procedures - Able to take oral medication. - May be required to identify an informant or caregiver who will be willing and able to supervise the daily dosing of study medications and to maintain control of study medications in the home. - A designated individual will be identified by the subject to participate in the ongoing consent process should the subject's cognitive capacity to consent become compromised during participation in the study. Exclusion Criteria: - History or known sensitivity of intolerability to CoQ. - Exposure to any investigational drug within 30 days of the Baseline visit. - Clinical evidence of unstable medical illness in the investigator's judgment. - Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression or suicidal ideation within 90 days of the Baseline visit. - Substance (alcohol or drug) abuse within one year of the Baseline visit. - Women who are pregnant or breastfeeding. - Use of supplemental coenzyme Q10 within 30 days prior to the Baseline visit - Clinically serious abnormalities in the screening laboratory studies (Screening creatinine greater than 2.0, alanine aminotransferase (ALT) or total bilirubin greater than 3 times the upper limit of normal, absolute neutrophil count of ≤1000/ul, platelet concentration of <100,000/ul, hematocrit level of <33 for female or <35 for male, or coagulation tests > 1.5 time upper limit of normal). - Known allergy to FD&C yellow #5 or any other ingredient in the study drug (active and placebo)

Gender: Both
Minimum Age: 16 Years
Maximum Age: N/A
Healthy Volunteers: No

Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment

NCT ID: NCT00489255

The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®

Condition:

Initial randomization is Tigan or Placebo (3:1) with phased withdrawal of Tigan to Placebo after 4 and 8 weeks. Subjects completing 4 weeks Tigan re-randomized to Tigan or Placebo (2:1) with patients completing 8 weeks Tigan re-randomized to receive Tigan or Placebo (1:1). Subjects randomized to Placebo over the previous 4 weeks assigned to continue on Placebo for the remainder of the study.

Eligibility:

Inclusion Criteria: - Subjects aged 18 years or over - Subjects with advanced Parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with Apokyn® by intermittent subcutaneous injection - Able to swallow Tigan®/placebo capsules - Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures - Women of child bearing potential must have a negative serum pregnancy test (beta hCG) prior to receiving study drug and must be using an appropriate form of contraception - Willing and able to provide informed consent Exclusion Criteria: - Hypersensitive to apomorphine hydrochloride or any of the ingredients of Apokyn® (notably sodium metabisulfite) - Hypersensitive to trimethobenzamide or any of the ingredients of Tigan® - Previous treatment with Apokyn® - Participation in any other clinical trial within 14 days of the present trial - Contraindications to Apokyn® or Tigan® - Currently taking, or likely to need to take at any time during the course of the study, any 5HT3 antagonist (ondansetron, alosetron, granisetron, palonosetron or dolasetron) - Malignant melanoma or a history of previously treated malignant melanoma - Pregnancy or breast feeding - Receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial - Any significant medical disorder, condition, concomitant medication or psychiatric disorder according to DSM-IV criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial

Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No

A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease

NCT ID: NCT01211587

The purpose of this research trial is to determine if safinamide (experimental drug) can improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The word "experimental" means the trial drug is not approved by Health Authorities (government authorities) and is still being tested for safety and effectiveness. Approximately one hundred (100) patients will participate in this research trial. The research trial will be conducted in approximately thirty (30) medical centers in the following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The research trial will last until June 2012.

Condition:

Eligibility:

Inclusion Criteria: - Male or female outpatients (aged 45 to 80 years inclusive) - Diagnosis of idiopathic Parkinson's Disease (PD) according to the UK PDS Brain Bank Criteria and a Hoehn and Yahr Stage of I to III (mild to moderate motor severity) at Screening. The diagnosis will be based on medical history and neurological examination - Subjects and informants must report cognitive impairment in at least one cognitive domain on the PD Cognitive Questionnaire (PD-CQ). - Cognitive impairment confirmed by a total score equal to- or below 26 on the Montreal Cognitive Assessment (MoCA) - Be able to speak, read, and write in the language in which the tests are written and must be able to perform all the assessments in this language - Receiving treatment with dopaminergic therapy (dopamine agonist and/or levodopa at a stable dose for at least four weeks prior to Screening and for the duration of the study) - Understand and sign the appropriate approved Informed Consent Form(s), one for the study (mandatory) and one for the pharmacogenetic evaluation (optional) Exclusion Criteria: - Any indication of forms of Parkinsonism other than idiopathic PD - Diagnosis of PD Dementia (probable, possible) according to the Clinical Diagnostic Criteria for Dementia Associated with PD - Diagnosis of Dementia with Lewy Bodies according to the McKeith criteria. - Subjects with any clinically significant DSM-IV-TR Axis I Disorders including major depression and severe anxiety; current diagnosis of substance abuse or history of alcohol or drug abuse for 3 months prior to Visit 1 (Screening) - Mental/physical/social condition which could preclude performing efficacy or safety assessments - Severe white matter disease, multiple lacunar infarcts, or signs of significant vascular changes on Magnetic Resonance Imaging (MRI) - Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such - Current history of severe dizziness or fainting on standing, due to postural hypotension - Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction in the three months prior to Visit 1 (Screening), or significant electrocardiogram (ECG) abnormality, including heart-rate corrected interval QT (QTC) > 450 milliseconds (males) or > 470 milliseconds (females), with QTC based on the Bazett's correction method - Known diagnosis of human immunodeficiency virus (HIV) infection, positive results on tests for hepatitis B or C antibodies, or on tests for hepatitis B surface antigen (unless vaccinated) - Neoplastic disease, either currently active or in remission for less than 1 year - Clinically significant or unstable gastrointestinal, renal, hepatic, endocrine, pulmonary, or cardiovascular disease, including not well controlled hypertension, asthma, chronic obstructive pulmonary disease, and Type 1 diabetes that would, in the opinion of the Investigator, preclude participation to the study - Any clinically relevant abnormality, either on medical history, physical and neurological examination, ECG, or by diagnostic laboratory tests that, in the opinion of the Investigator, could hinder participation to the study - Currently experiencing end-of-dose wearing-off or on-off phenomena, disabling peak dose- or biphasic dyskinesia, or unpredictable or widely swinging fluctuations - Any medical conditions and/or taking concomitant medications that could put them at risk, interfere with study evaluations, or prevent meeting the requirements of the study - Currently participating to another clinical trial or who participated in a previous clinical trial within 30 days prior to Visit 1 (Screening) or who received any investigational product within 30 days or five half-lives, whichever was longer, prior to Visit 1 (Screening) - Previously treated with safinamide - Clinically significant hypertension or contraindications or hypersensitivity to monoamine oxidase-Type B (MAO-B) inhibitors - Anticholinergic medication and/or amantadine within 4 weeks prior to the Screening visit - Opioids (e.g., tramadol and meperidine derivatives) or MAO inhibitors (e.g., selegiline) within 8 weeks prior to Visit 1 (Screening) Dextromethorphan will be allowed to treat cough. One tricyclic- or tetracyclic antidepressant or trazodone will be permitted if taken at bedtime at a low dose as a sleeping aid - Acetylcholinesterase inhibitors or memantine within 4 weeks before start of the study treatment or requiring these medications during the treatment period - Depot neuroleptic during the study or within 1 injection cycle or oral neuroleptics (stable dose of quetiapine less than 100 mg/day for 8 weeks prior to Visit 1 will be allowed) within 4 weeks prior to Visit 1 (Screening) - Drug that has hepatotoxic potential (e.g., tamoxifen) within 4 weeks prior to Visit 1 (Screening), or radiation therapy, or a drug with cytotoxic potential (e.g., chemotherapy) within 1 year prior to the Screening visit. - Subjects who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study - Women who are pregnant, lactating, or who are attempting to conceive - Women of childbearing potential not willing to use an adequate contraceptive method (unless surgically sterilized) for 4 weeks prior to, during, and 4 weeks after the last dose of trial medication - Clinically significant ophthalmologic abnormality such as patients with albinism, family history of hereditary retinal disease, progressive and/or severe diminution of corrected visual acuity, retinitis pigmentosa, any active retinopathy or ocular inflammation (uveitis), or progressive, severe diabetic retinopathy - Known hypersensitivity to the trial treatment(s), including placebo or other comparator drug(s) - Legal incapacity or limited legal capacity

Gender: Both
Minimum Age: 45 Years
Maximum Age: 80 Years
Healthy Volunteers: No

Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)

NCT ID: NCT01060878

A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.

Condition:

Eligibility:

Inclusion Criteria: - confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening - subjects who are not currently receiving any PD treatment Exclusion Criteria: - female of child-bearing potential - history of neurosurgical procedures for PD - history of severe psychiatric illness

Gender: Both
Minimum Age: 35 Years
Maximum Age: 75 Years
Healthy Volunteers: No

Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

NCT ID: NCT00712426
Principal Investigator: Steven M Hersch, MD, PhD

Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.Creatine monohydrate is considered a nutritional supplement. The purpose of CREST-E is to test whether high-dose creatine can slow the progressive functional decline that occurs in persons 18 years or older with early clinical features of HD. The long-term safety, tolerability and effectiveness of up to 40 grams daily creatine compared to placebo is studied. A variety of biological processes are assessed for markers of disease activity or progression and creatine effects. Up to 50 active research centers globally will enroll 650 subjects.

Condition:

Eligibility:

Inclusion Criteria: - Male or female ages 18 or older. - Clinical features of HD AND confirmatory family history of HD; OR Clinical features of HD AND CAG repeat expansion greater or equal to 36. - Stage I or II of illness (TFC greater or equal to 7). - Ambulatory and not requiring skilled nursing care at the time of enrollment. - Must be capable of providing informed consent and complying with trial procedures. - Additional inclusion criteria apply. Exclusion Criteria: - History of known sensitivity or intolerability to creatine monohydrate. - Exposure to any investigational drug within 30 days of randomization (Baseline visit). - Use of supplemental creatine at a dose greater than 10 grams within 30 days of randomization (Baseline visit). - Screening laboratory abnormalities that in the judgment of the investigator would jeopardize safe conduct of study. - Clinical evidence of unstable medical illness. - Clinical evidence of unstable psychiatric illness. - Additional exclusion criteria apply.

Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No

Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)

NCT ID: NCT01132326
Principal Investigator: Horacio Kaufmann, MD

Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge resulting in symptomatic cerebral-hypoperfusion. Droxidopa augments norepinephrine levels which should lead to improved cerebral perfusion following orthostatic challenge thereby reducing the symptoms of NOH. The present study will evaluate the long-term safety of droxidopa.

Condition:

This is a Phase III, multi-center, open-label study designed to evaluate the long-term safety of droxidopa in subjects with neurogenic orthostatic hypotension (NOH) associated with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Autonomic Neuropathy. Patients will be initially treated with droxidopa at their individualized dose identified during the titration phase in Protocol 301. Patients will not require adjustment of their dose, unless their physician feels a dose change will benefit their symptoms, or side effects. At any point in the study a patient's physician may elect to titrate the subject to a higher or lower dose if they feel additional benefit can be safely derived or to deal with any unwanted side-effect. Patients will return to the clinic for study visits at 1, 3, 6, 9 and 12 months (± 1 week allowed for 1 month visit, ± 2 weeks allowed for subsequent study visits). Patients who prematurely withdraw from the study will be asked to attend the study center for a final assessment At the conclusion of the 12 month treatment period, all patients who benefit from treatment with droxidopa will be offered the option to continue to receive open-label droxidopa through a separate access program. At any time during the study, patients can schedule a visit with their study physician if they experience a worsening of symptoms and wish to have their dose adjusted or to remove themselves from the trial. Patients who decide to terminate their participation in the study will receive a phone call 1 month after leaving the trial to follow-up on any new or ongoing adverse events (AEs). It is a recognized best practice that patients with neurogenic orthostatic hypotension are advised not to lay fully supine because of the associated increased risk of supine hypertension inherent with their condition. Patients participating in this study should be advised to sleep in a semi-recumbent position. . Patients will attend the study center as out-patients. Patients will be identified using the unique identification number assigned during Protocol 301.

Eligibility:

Inclusion Criteria: To be eligible for inclusion, each patient must fulfill the following criteria: - Demonstrated a symptomatic response (an improvement of at least 1 point in Item #1 of the OHSA) to treatment with droxidopa during open-label titration in Droxidopa Protocol 301 ; - Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care. Exclusion Criteria: Patients are not eligible for this study if they fulfill one or more of the following criteria: - Currently taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine; patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their study entry visit (Visit 1). - Currently taking anti-hypertensive medication; the use of short-acting anti-hypertensive medications at bedtime is permitted. - Currently taking tri-cyclic antidepressant medication or other norepinephrine re-uptake inhibitors; - Have changed dose, frequency and or type of prescribed medication, within two weeks of starting droxidopa treatment within Protocol 304, with the following exceptions: - vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine (see exclusion a), - short courses of antibiotics or other medications/treatments that do not interfere with, or exacerbate the patient's condition under study. - History of known or suspected drug or substance abuse; - Women of childbearing potential who are not using a medically accepted contraception; - Reproductive potential: Female subjects should be either post-menopausal (amenorrhoea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) who are using or agree to use acceptable methods of contraception. Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. - For WOCP a serum beta HCG pregnancy test must be conducted at screening, and a urine pregnancy test must be conducted at baseline and study termination; the results must be negative at screening and at baseline for the patient to receive study medication. WOCP must be advised to use acceptable contraceptives throughout the study period and for 30 days after the last dose of investigational product. If hormonal contraceptives are used they should be taken according to the package insert. WOCP who are not currently sexually active must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of the study and for 30 days after the last dose of investigational product. - Sexually active males whose partner is a WOCP and who do not agree to use condoms for the duration of the study and for 30 days after the last dose; - Women who are pregnant or breast feeding; - Known or suspected hypersensitivity to the study medication or any of its ingredients; - Pre-existing, sustained, severe hypertension (BP greater than or equal to 180/110 mmHg in the sitting position); - Have atrial fibrillation or, in the investigator's opinion, have any other significant cardiac arrhythmia; - Any other significant systemic, hepatic, cardiac or renal illness; - Diabetes mellitus or insipidus; - Have a history of closed angle glaucoma; - Have a known or suspected malignancy; - Patients with known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug; - In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing; - In the investigator's opinion, are unable to adequately co-operate because of individual or family situation; - In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia; - Are not able or willing to comply with the study requirements for the duration of the study; - Have participated in another clinical trial with an investigational agent other than droxidopa (including named patient or compassionate use protocol) within 4 weeks before starting droxidopa treatment within Protocol 304; - Previous enrolment in the study.

Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No

A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease

NCT ID: NCT01176240
Principal Investigator: Robert Hauser, M.D.

This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug. Symptoms of NOH may include any of the following: - Dizziness, light-headedness, feeling faint or feeling like you may blackout - Problems with vision (blurring, seeing spots, tunnel vision, etc.) - Weakness - Fatigue - Trouble concentrating - Head & neck discomfort (the coat hanger syndrome) - Difficulty standing for a short time or a long time - Trouble walking for a short time or a long time The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.

Condition:

Systolic blood pressure is transiently and minimally decreased in healthy individuals upon standing. Normal physiologic feedback mechanisms work through neurally-mediated pathways to maintain the standing blood pressure, and thus maintain adequate cerebral perfusion. The compensatory mechanisms that regulate blood pressure upon standing are dysfunctional in subjects with orthostatic hypotension (OH), a condition that may lead to inadequate cerebral perfusion with accompanying symptoms of syncope, dizziness or lightheadedness, unsteadiness and blurred or impaired vision, among other symptoms. Orthostatic hypotension may be a severely disabling condition which can seriously interfere with the quality of life of afflicted subjects. Currently available therapeutic options provide some symptomatic relief in a subset of subjects, but are relatively ineffective and are often accompanied by severe side effects that limit their usefulness. Support garments (tight-fitting leotard) may prove useful in some subjects, but is difficult to don without family or nursing assistance, especially for older subjects. Midodrine, fludrocortisone, methylphenidate, ephedrine, indomethacin and dihydroergotamine are among some of the pharmacological interventions that have been used to treat orthostatic hypotension, although only midodrine is specifically approved for this indication. The limitations of these currently available therapeutic options, and the incapacitating nature and often progressive downhill course of disease, point to the need for an improved therapeutic alternative. Symptomatic OH in patients with Parkinson's disease is thought to be a consequence of norepinephrine depletion leading to low systolic blood pressure (SBP) and cerebral-hypoperfusion (reduced blood flow to the brain). Therapy with droxidopa results in increased levels of norepinephrine which should lead to improved SBP and cerebral perfusion thereby reducing the signs and symptoms of NOH. The present study will evaluate the clinical benefit in NOH patients with PD treated with droxidopa compared to those treated with placebo. Participation in the study will last a maximum of 14 weeks consisting of a 2 week (maximum) screening/baseline period; a 2 week (maximum) double-blind dose titration; an 8 week double-blind placebo-controlled treatment period; and a 2 week follow-up period. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only. Droxidopa: Droxidopa [also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS] is the International non-proprietary name (INN) for a synthetic amino acid precursor of norepinephrine (NE), which was originally developed by Sumitomo Pharmaceuticals Co., Limited, Japan. It has been approved for use in Japan since 1989. Droxidopa has been shown to improve symptoms of orthostatic hypotension that result from a variety of conditions including Shy Drager syndrome (Multiple System Atrophy), Pure Autonomic Failure, and Parkinson's disease. There are four stereoisomers of DOPS; however, only the L-threo-enantiomer (droxidopa) is biologically active. Stereoisomers and enantiomers are compounds that have the same chemical elements; however, they may react differently as the elements are positioned in different locations. The exact mechanism of action of droxidopa in the treatment of symptomatic NOH has not been precisely defined; however, its NE replenishing properties with concomitant recovery of decreased noradrenergic activity are considered to be of major importance. Droxidopa has been marketed in Japan since 1989. Data from clinical studies and post-marketing surveillance programs conducted in Japan show that the most commonly reported adverse drug reactions with droxidopa are increased blood pressure, nausea, and headache. In clinical studies, the prevalence and severity of droxidopa adverse effects appear to be similar to those reported by the placebo control arm.

Eligibility:

Inclusion criteria: 1. 18 years or over 2. Clinical diagnosis of Parkinson's disease 3. Clinical diagnosis of symptomatic neurogenic orthostatic hypotension At their baseline visit (Visit 2), patients must demonstrate: - a score of at least 3 or greater on the OHQ composite - a score of at least 3 or greater on the clinician CGI-S - a fall of at least 20 mmHg in their systolic blood pressure, or 10 mmHg in their diastolic blood pressure, within 3 minutes of standing 4. Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care Exclusion Criteria: 1. Score of 23 or lower on the mini-mental state examination (MMSE) 2. Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure; - Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2) and throughout the duration of the study 3. Concomitant use of anti-hypertensive medication for the treatment of essential hypertension 4. Have changed dose, frequency or type of prescribed medication, within two weeks of baseline visit (Visit 2) with the following exceptions: - Vasoconstricting agents such a ephedrine, dihydroergotamine, or midodrine - Short courses (less than 2 weeks) of medications or treatments that do not interfere with, or exacerbate the patient's condition under study (e.g. antibiotics) 5. Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse) 6. Women who are pregnant or breastfeeding 7. Women of child bearing potential (WOCP) who are not using at least one method of contraception with their partner 8. Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using at least one method of contraception 9. Untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the patient 10. Sustained severe hypertension (BP ≥ 180 mmHg systolic or ≥ 110 mmHg diastolic in the seated or supine position which is observed in 3 consecutive measurements over an hour) 11. Any significant uncontrolled cardiac arrhythmia 12. History of myocardial infarction, within the past 2 years 13. Current unstable angina 14. Congestive heart failure (NYHA Class 3 or 4) 15. Diabetic autonomic neuropathy 16. History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ 17. Gastrointestinal condition, which in the Investigator's judgment, may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass) 18. Any major surgical procedure within 30 days of the baseline visit (Visit 2) 19. Previously treated with droxidopa 20. Currently receiving any investigational drug or have received an investigational drug within 30 days of the baseline visit (Visit 2) 21. Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study. Additionally the Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures.

Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No

Pioglitazone in Early Parkinson's Disease

NCT ID: NCT01280123

This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility. Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no more than 8 months, will be randomized to one of two dosages of oral pioglitazone (15 mg and 45 mg) or matching placebo. The study will measure disease progression by the change in total UPDRS score between the baseline visit and 44 weeks.

Condition:

A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's Disease. The patient population has early stage PD (< 5 years from diagnosis), must be treated with 1 mg/day of rasagiline or 10 mg/day of selegiline for at least 8 weeks but not more than 8 months prior to enrollment. The primary objective of this clinical trial is to assess the futility of pioglitazone on PD disease progression as measured by the change in total UPDRS score between the baseline visit and 44 weeks. The secondary objectives of the study are to collect additional efficacy and safety/tolerability data to be used in planning a subsequent Phase III trial of pioglitazone in early, treated PD. Measures of cognition, mood and blood- and urine-based biomarkers will also be explored. Subjects in this trial are randomly assigned in a 1:1:1 ratio to one of three study arms: 15 mg, 45 mg or placebo.

Eligibility:

Inclusion Criteria: 1. Willing and able to give informed consent. 2. Men and women with idiopathic PD of less than 5 years duration from diagnosis with a Hoehn and Yahr Stage < 2. 3. On stable dosage of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but not more than 8 months prior to baseline. Expected to remain on stable dose of rasagiline or selegiline as the only treatment for their PD for the duration of the study (44 weeks). 4. Diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity) being present, without any other known or suspected cause of parkinsonism. The clinical signs must be asymmetric. 5. Subjects may be taking stable doses (30 days) of anticholinergics or creatine (< 5gm/day) but must be expected to remain on the same dose. 6. Age > 30 years. 7. Women who are not postmenopausal or surgically sterile must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Exclusion Criteria: 1. Exposure to dopaminergic PD therapy or amantadine within 60 days prior to baseline visit or for 90 days or more at any point in the past 2. Use of any of the following drugs within 180 days prior to baseline: neuroleptics, metoclopramide, alpha-methyldopa, clozapine, olanzapine and flunarizine. 3. Use of any of the following drugs within 90 days prior to baseline: methylphenidate, cinnarizine, reserpine, tetrabenazine, amphetamine or MAO-A inhibitors (pargyline, phenelzine, and tranylcypromine). 4. Presence of drug-induced parkinsonism (e.g., metoclopramide, flunarizine), metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or other atypical Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy). 5. Participation in other drug studies or receipt of other investigational drugs within 30 days prior to baseline or during the study. 6. Presence of freezing. 7. Any clinically significant psychiatric or medical condition or laboratory abnormality, which would in the judgment of the Investigator interfere with the subject's ability to participate. 8. History of stereotaxic brain surgery for PD 9. Clinically significant structural brain disease that the investigator believes would interfere with study evaluations. 10. History of congestive heart failure. 11. Use of pioglitazone or rosiglitazone within 90 days before randomization. 12. Known intolerance to pioglitazone or rosiglitazone. 13. Allergy to rasagiline or selegiline, or contraindication to rasagiline or selegiline use. 14. Type I or Type II diabetes mellitus. 15. HgbA1C greater than or equal to 6% at Screening. 16. Known liver disease or elevation of AST or ALT greater than 2.5 times the upper limit of normal. 17. Known history of osteoporosis. All women ≥ 65 years of age or men and woman at high risk of osteoporosis should have documented evidence of screening for osteoporosis. Factors associated with high risk of osteoporosis include: previous non traumatic fracture, chronic glucocorticoid use, body weight under 58 kg, family history of hip fracture, current cigarette smoking, and excessive alcohol intake. 18. Drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with the safe conduct of the study. 19. Significant peripheral edema (2+ or more) of the extremities of any etiology. 20. Current or planned use of gemfibrozil or rifampin during the trial. 21. History of bladder cancer. 22. Evidence of hematuria which has not been evaluated for evidence of bladder cancer. (Documentation of work up or a repeat urine test that was negative for hematuria and the PCP or urologist does not feel that further work up is required.) 23. History of macular edema.

Gender: Both
Minimum Age: 30 Years
Maximum Age: N/A
Healthy Volunteers: No

Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)

NCT ID: NCT01060878

A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.

Condition:

Eligibility:

Inclusion Criteria: - confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening - subjects who are not currently receiving any PD treatment Exclusion Criteria: - female of child-bearing potential - history of neurosurgical procedures for PD - history of severe psychiatric illness

Gender: Both
Minimum Age: 35 Years
Maximum Age: 75 Years
Healthy Volunteers: No

Pregabalin (Lyrica) for the Treatment of Essential Tremor

NCT ID: NCT00584376
Principal Investigator: Theresa A Zesiewicz, MD

This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET.

Condition:

Eligibility:

Inclusion Criteria: 1. Outpatients with essential tremor diagnosed by a movement disorder specialist. 2. Age 18 years to 80 years. 3. Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale. 4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study. 5. Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year). 6. Serum creatine kinase, complete metabolic blood count, liver function tests, renal function tests, and platelets are within normal limits (blood drawn within the past year). 7. Stable doses of all medications for 30 days prior to study entry and for the duration of the study. Exclusion Criteria: 1. Any illness that in the investigator's opinion preclude participation in this study. 2. Pregnancy or lactation. 3. Concurrent participation in another clinical study. 4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24). 5. Legal incapacity or limited legal capacity. 6. Presence of severe renal disease (BUN 50% greater than normal or creatine clearance <60 mL/min) or hepatic disease. 7. Presence of severe daytime sleepiness. 8. Abnormal creatine kinase and/or platelet count in the past year. 9. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities. 10. Previous lack of response to other ET therapies (propranolol AND primidone). 11. Patients who have had deep brain stimulation (DBS). 12. Concomitant treatment with gabapentin.

Gender: Both
Minimum Age: 18 Years
Maximum Age: 80 Years
Healthy Volunteers: No

NET-PD LS-1 Creatine in Parkinson's Disease

NCT ID: NCT00449865
Principal Investigator: Karl Kieburtz, MD

The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.

Condition:

Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die. This study will determine if creatine——an investigational compound——is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells. In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.

Eligibility:

Inclusion Criteria: - Willing and able to give informed consent and willing to commit to long-term follow-up - PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis - Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years. Exclusion Criteria: - Use of creatine 14 days prior to baseline or during the study - History of known hypersensitivity or intolerability to creatine - Any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up - Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.

Gender: Both
Minimum Age: N/A
Maximum Age: N/A
Healthy Volunteers: No

A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

NCT ID: NCT00387075
Principal Investigator: Danna Jennings, MD

This study is designed as a prospective cohort study to test the strategy of combining two biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug, [123I]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish an 'at risk' Parkinson disease cohort without motor symptoms of PD. First-degree relatives of PD will be recruited through PD research sites and national foundations to participate in this study. In addition, first degree relatives of PD patients will be recruited directly through advertising.

Condition:

First-degree relatives that agree to participate (n=3,000) will be asked to complete a 40-item olfactory identification test provided by mail. 300 subjects (225 with decreased odor identification and 75 with normal olfaction) will be invited to undergo DAT imaging at the Institute for Neurodegenerative Disorders in New Haven, CT. There will also be additional clinical follow-up at participant's clinical (local) site. The primary outcome measure for the study will be the mean striatal uptake of [123I]B-CIT in first-degree relatives with a loss of odor identification, which will be compared to an established healthy control database (age 40-70; n=50). 300 relatives will be followed longitudinally with clinical evaluations and a second imaging study completed after two years. Comparing the first and second scans in this subset of subjects will allow us to evaluate the rate of progressive loss in dopamine transporter density during this pre-symptomatic period.

Eligibility:

Inclusion Criteria: - subject must have a first-degree relative with PD, based on their report - subject must be either at least 50 yrs old or within 10 yrs of the age of onset of their affected relative Exclusion Criteria: - diagnosis of PD or other neurodegenerative disorder - other known reason for abnormal olfaction (e.g. nasal trauma, sinus infection, sinus surgery) - pregnancy, if participating in the imaging portion of this study

Gender: Both
Minimum Age: 50 Years
Maximum Age: N/A
Healthy Volunteers: No

Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)

NCT ID: NCT01227265

This is a study of the efficacy and safety of preladenant in adult participants with moderate to severe Parkinson's Disease (PD). While on this study, participants will continue to take their usual, prescribed, stable regimen of L-dopa or L-dopa plus adjunct PD medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or placebo, twice daily, for 12 weeks. After that, participants may choose to receive additional treatment with preladenant.

Condition:

Eligibility:

Inclusion Criteria: - Each participant must have a diagnosis of idiopathic Parkinson's disease. - Each participant must have received prior therapy with L dopa for approximately 1 or more years immediately before Screening and must continue to have a beneficial clinical response to L-dopa. - Each participant must have been on a stable dopaminergic treatment regimen for at least the 5 weeks immediately before Randomization. Participants receiving other adjunctive treatments (eg, dopamine agonist, anticholinergics) are permitted to enroll in this trial. Participants taking only L dopa are permitted to enroll in this trial. - Each participant must be experiencing motor fluctuations with or without dyskinesias within the 4 weeks immediately before Screening, must be experiencing a minimum of 2 hours/day of "off" time, and have a Hoehn & Yahr stage between 2.5 and 4 when in the "on" state. - Each participant, with or without the help of a caregiver, must be capable of maintaining an accurate and complete symptom diary and to adhere to dose and visit schedules. - Each participant must have results of Screening clinical laboratory tests drawn within 4 weeks prior to Randomization clinically acceptable to the investigator and not within the parameters specified for exclusion (below). - All participants who are sexually active or plan to be sexually active agree to use a highly effective method of birth control while in the study and for 2 weeks after the last dose of study drug. A male participant must also not donate sperm within 2 weeks after the last dose of study drug. Exclusion Criteria: - A participant must not have a form of drug induced or atypical parkinsonism, a cognitive impairment, bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator. - A participant must not have a history of repeated strokes or head injuries, or a stroke within 6 months of Screening; poorly controlled diabetes; abnormal renal function; or a severe or ongoing unstable medical condition. - A participant must not have had surgery for their PD. - A participant must not be at imminent risk of self-harm or harm to others. - A participant must not have a systolic blood pressure (BP) ≥150 mm Hg OR diastolic BP ≥95 mm Hg at Screening and at 2 BP rechecks prior to study start. - A participant must not have had any clinically significant cardiovascular event or procedure for 6 months prior to study start, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and a participant must not have heart failure staged New York Heart Association Class III or IV. - A participant must not have an alanine aminotransferase (ALT) or aspartate amino transferase (AST) ≥3 x the upper limit of normal (ULN) or total bilirubin (T BIL) ≥1.5 x ULN. - A participant must not have a history of serologically confirmed hepatic dysfunction (defined as viral infection [Hepatitis B or C; Epstein Barr virus (EBV); cytomegalovirus (CMV)]) or a history of diagnosis of drug or alcohol induced hepatic toxicity or frank hepatitis. - A participant must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection. - A participant must not have received certain prespecified medications for a prespecified time window before the trial. - A participant must not have an average daily consumption of more than three 4 ounce glasses (118 mL) of wine or the equivalent. - A participant must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence). - A participant must not have allergy/sensitivity to investigational product(s) or its/their excipients. - A participant must not be breast-feeding, considering breast-feeding, pregnant, or intending to become pregnant. - A participant must not have used preladenant ever, or any investigational drugs within 90 days immediately before Screening.

Gender: Both
Minimum Age: 30 Years
Maximum Age: 85 Years
Healthy Volunteers: No

Risk Factors for Progressive Supranuclear Palsy (PSP)

NCT ID: NCT00431301
Principal Investigator: Irene Litvan, M.D.

Progressive supranuclear palsy (PSP) is the most common atypical parkinsonian movement disorder. This study will determine the role of specific genetic, occupational and environmental components in the development of PSP by evaluating patients with this disorder and age and gender matched controls.

Condition:

This proposal will determine: (1) if there is an association between PSP and specific genes of interest; (2) if there is an association between PSP and occupational and/or environmental chemical exposures functionally or structurally similar to known parkinsonian toxicants; and (3) if hypertension or traumatic brain injury prior to symptom-onset is associated with PSP. To disentangle the complex etiology of PSP, this case-control multicenter study involves 500 PSP cases, 500 age/gender matched primary controls, and 500 secondary controls for genetic confirmation. Understanding the etiology of PSP may also help explain the causes of other related diseases such as Alzheimer's disease. This multidisciplinary team of movement disorder specialists, epidemiologists, geneticists, biostatisticians, industrial hygienist and toxicologist is well suited to unravel the etiology of PSP.

Eligibility:

Inclusion Criteria: - PSP patients able to visit one of the screening sites for diagnostic confirmation and able to participate in a one hour telephone interview Exclusion Criteria: - No other major neurological disorders - Unable to communicate by telephone

Gender: Both
Minimum Age: 40 Years
Maximum Age: N/A
Healthy Volunteers: Accepts Healthy Volunteers

Effects of Coenzyme Q10 (CoQ) in Parkinson Disease

NCT ID: NCT00740714
Principal Investigator: M. Flint Beal, MD

The purpose of this study is to evaluate the safety and effectiveness of high dosages of Coenzyme Q10 in slowing clinical decline in people who have early Parkinson disease.

Condition:

Parkinson disease (PD) is a progressive neurodegenerative disease that affects more than 1,000,000 Americans. Currently there is no proven therapy to reduce the rate of progression of PD. In a previous phase II clinical trial, investigators demonstrated that Coenzyme Q10 (CoQ) at dosages of 300, 600, and 1200 mg/day was safe and well-tolerated in individuals with early, untreated PD. The findings also suggested that CoQ may slow the progressive impairment of PD as measured by the Unified Parkinson Disease Rating Scale (UPDRS). In this study, researchers will conduct a randomized, placebo-controlled, phase III trial of CoQ to confirm and extend the results of the earlier phase II study. The primary objective of this trial is to compare the effect of two dosages of CoQ (1200 and 2400 mg/day) and placebo on the total UPDRS score in people with early PD. The study also will evaluate independent function, cognition, and quality of life. Plasma CoQ levels will be measured at months 1, 8 and 16 and correlated with changes in UPDRS scores. Participants will be randomly assigned to receive a placebo (an inactive substance), 1200 mg/d CoQ, or 2400 mg/d CoQ. They will be evaluated at screening, baseline, and during visits at months 1, 4, 8, 12, and 16. Information gained from this trial could lead to changes in management of people with early PD.

Eligibility:

Inclusion Criteria: - Presence of all 3 of the cardinal features of Parkinson disease (resting tremor, bradykinesia and rigidity). The clinical signs must be asymmetric. - The diagnosis of Parkinson disease within 5 years prior to the Screening Visit. - Age 30 or older. - Female subjects must not be of childbearing potential or must use an approved form of contraception for the duration of the trial. Exclusion Criteria: - Use of any Parkinson disease medication within 60 days prior to the Baseline Visit. - Duration of previous use of symptomatic medication for Parkinson disease cannot exceed 90 days such as levodopa, dopaminergic agonists (including ropinirole, pramipexole, pergolide, cabergoline, and the rotigotine transdermal system), selegiline, rasagiline, amantadine, and anticholinergic agents. - Parkinsonism due to drugs including neuroleptics, alphamethyldopa, reserpine, metoclopramide, valproic acid. - Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin. - Other parkinsonian disorders. - Modified Hoehn and Yahr score of 3 or greater at Screening Visit or Baseline Visit. - UPDRS tremor score of 3 or greater at Screening Visit or Baseline Visit. - Mini-Mental State Examination (MMSE) score of 25 or less. - History of stroke. - Disability sufficient to require treatment with dopaminergic medication or anticipated need for dopaminergic medication within next 3 months. - Other serious illness, including psychiatric illness. - Patients with active cardiovascular, peripheral vascular or cerebrovascular disease within the past year. - Clinically serious abnormalities in the Screening Visit laboratory studies or electrocardiogram. - Use of methylphenidate, cinnarizine, reserpine, amphetamine or a MAO-A inhibitor within 6 months prior to the Baseline Visit. - Unstable dose of CNS active therapies. - Use of appetite suppressants within 60 days prior to the Baseline Visit. - History of active epilepsy within the last 5 years. - Revised Hamilton Rating Scale for Depression of 11 or greater. - Participation in other drug studies or use of other investigational drugs within 30 days prior to Screening Visit. - History of electroconvulsive therapy. - History of any brain surgery for Parkinson disease. - History of structural brain disease such as prior trauma causing damage detected on a CT scan or MRI, hydrocephalus, or prior brain neoplasms.

Gender: Both
Minimum Age: 30 Years
Maximum Age: N/A
Healthy Volunteers: No

Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease

NCT ID: NCT00909545

The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.

Condition:

There is solid scientific rational and preclinical data supporting a clinical trial of isradipine CR as a potential disease modifying agent in early PD. Human pharmacokinetic data demonstrate that it is feasible to achieve the serum concentrations in humans that were neuroprotective in preclinical models with the FDA approved dosage range. Pilot data demonstrate acceptable tolerability of isradipine CR in the PD population. Tolerability is inversely proportional to the dosage dependent. Considering that tolerability of isradipine CR is inversely proportional to the dosage exposure, it is essential to proceed with the dose selection tolerability study in preparation for the future efficacy trials. The tolerability, defined as the ability to complete the study, of three dosages of isradipine CR relative to placebo in subjects with early Parkinson's disease will be examined first. The dosage that is tolerable and demonstrates preliminary efficacy will be evaluated further in the future pivotal efficacy studies.

Eligibility:

Inclusion Criteria: - Subjects with early idiopathic PD. If tremor is not present, subjects must have unilateral onset and persistent asymmetry of the symptoms. - Be over 30 years old at the time of diagnosis of PD. - Hoehn & Yahr stage is less than or equal to 2.5. - Currently not receiving dopaminergic therapy and not projected to require dopaminergic therapy for at least 6 months from enrollment. - Use of MAO-B inhibitors (rasagiline, selegiline), amantadine, or anticholinergics will be allowed. The dosage has to be stable for 3 months prior to baseline visit and throughout the duration of the study. Exclusion Criteria: - Subjects with a diagnosis of an atypical Parkinsonism - Subjects unwilling or unable to give informed consent - Use of CoQ10 at a dosage >600mg daily or use of creatine >5 grams daily within the 60 days prior to randomization - Exposure to dopaminergic PD therapy within 60 days prior to enrollment or for 3 months or more at any point in the past - History of clinically significant orthostatic hypotension or presence of orthostatic hypotension at the screening visit defined as > 20 mmHg change in systolic BP and >10mm change in diastolic BP after 2 min of standing, or baseline BP <90/60 - History of congestive heart failure - History of bradycardia defined as heart rate <55 - Presence of 2nd or 3rd degree atrioventricular block or other significant ECG abnormalities that in the investigator's opinion would compromise participation in study - Clinically significant abnormalities in the Screening Visit laboratory studies or electrocardiogram. - Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study - Prior exposure to isradipine or other calcium channel blockers within 6 months of baseline - Subjects with history of hypertension treated with a maximum of 2 other antihypertensive agents will be allowed provided that the doses of concomitant anti HTN therapy can be reduced/adjusted during the study based on the BP readings in consultation with the subject's primary care physician or cardiologist. - Use of grapefruit juice, Ginkgo biloba, St. John's wart and/or ginseng will be prohibited during the study (as they interfere with the metabolism of isradipine). - Presence of cognitive dysfunction defined by a Mini Mental Status Exam ( MMSE) score < 26 at screening - Subjects with clinically significant depression as determined by a Beck Depression Inventory (BDI) score >15 at screening - History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to enrollment - Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to enrollment - Lactating women or women of childbearing potential who are not surgically sterilized have to use a reliable measure of contraception and have a negative serum pregnancy test at screening - Participation in other investigational drug trials within 30 days prior to screening - History of brain surgery for PD

Gender: Both
Minimum Age: 30 Years
Maximum Age: N/A
Healthy Volunteers: No

Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

NCT ID: NCT01283594

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.

Condition:

Eligibility:

Inclusion Criteria: - Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria - Meet Hoehn and Yahr PD stage - Good response to levodopa - Stable regimen of anti-parkinson medications - Are able to complete a Parkinson's disease diary - If of childbearing potential(male and female), use an acceptable method of birth control - Able and willing to sign an IRB/IEC approved informed consent - Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests. Exclusion Criteria: - Secondary or atypical Parkinson's - Neurosurgical intervention for Parkinson's disease - Treatment with apomorphine - Treatment with anti-psychotic drugs - Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation - MMSE less than 26 - Subjects with untreated or uncontrolled current episode of major depression - Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses <100mg per day) - Women pregnant or lactating - History of hepatitis, cholangitis - Untreated or uncontrolled hypothyroidism or hyperthyroidism - Drops in blood pressure requiring medication to maintain blood pressure - Any clinically significant out of range laboratory evaluations - Known sensitivity to the study medication or its components - Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale - Finding of malignant melanoma on full body skin exam - Impulse disorder conditions

Gender: Both
Minimum Age: 30 Years
Maximum Age: 80 Years
Healthy Volunteers: No

Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression

NCT ID: NCT01141023
Principal Investigator: Kenneth L Marek, MD

This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

Condition:

PPMI will be a five-year natural history study (a minimum of 3-year involvement for each subject) of de novo idiopathic PD patients and healthy controls. This study will also include a SWEDD (subjects without evidence of dopaminergic deficit)and Prodromal populations. All subjects will be comprehensively assessed at baseline and every three to six months thereafter. Subjects will undergo clinical (motor, neuropsychiatric and cognitive) and imaging assessments and will donate blood, urine, and cerebral spinal fluid (CSF). A blood sample for DNA will be collected. Data will be collected by each site under uniformly established protocols and data will be analyzed and stored at designated core facilities.

Eligibility:

Inclusion Criteria: Parkinson Disease (PD) Subjects: - A diagnosis of Parkinson disease for 2 years or less at Screening. - Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit, or if applicable a VMAT-2 PET scan consistent with vesicular monoamine transporter deficit. - Not expected to require PD medication with at least 6 months from Baseline. - Male or female age 30 years or older at time of PD diagnosis. Healthy Control (HC) Subjects: • Male or female age 30 years or older at Screening. Exclusion Criteria: Parkinson Disease (PD) Subjects: - Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or other PD medication. - Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline. - Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 60 days. - Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. - Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ or amphetamine type medications. - Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. - Use of investigational drugs within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). Healthy Control (HC) Subjects: - Current or active neurological disorder. - First degree relative with idiopathic PD (parent, sibling, child). - MoCA score < 26. - Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ) or amphetamine type medications. - Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. - Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. - Use of other investigational drugs within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). SWEDD Subjects: All PD criteria apply, as above, except a SWEDD subject must have confirmation from imaging core that screening dopamine transporter SPECT scan shows no evidence of dopamine transporter deficit or if applicable a VMAT-2 PET scan shows no evidence of vesicular monoamine transporter deficit. Prodromal Subjects: Inclusion Criteria (Prodromal Subjects) 4.2.7.1. Subjects must have at least one of the following characteristics: Hyposmia: 1. Male or female age 60 years or older 2. Confirmation from olfactory core that olfaction as determined by UPSIT is at or below the 10th percentile by age and gender REM Behavior Disorder (RBD): 1. Male or female age 60 years or older 2. Confirmation from sleep core that subject's Polysomnography (PSG) meets criteria for RBD LRRK2: 1. Male or female age 60 years or older 2. Written confirmation or documentation from testing facility that the individual is LRRK2 mutation positive 4.2.7.2. Confirmation from imaging core that screening dopamine transporter SPECT scan is read as eligible (see below). About 80 subjects will have a range of DAT deficit similar to subjects with early PD (mild to moderate DAT deficit). About 20 subjects will be selected with no DAT deficit or minimal DAT deficit similar in age, gender, and risk profile to those with mild to moderate DAT deficit. 4.2.7.3. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 4.2.7.4. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 4.2.7.5. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Includes a negative urine pregnancy test on day of screening scan prior to injection (DaTSCAN). Exclusion Criteria (Prodromal Subjects) 1. Current or active clinically significant neurological disorder or psychiatric disorder (in the opinion of the Investigator). 2. GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study). 3. STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study. 4. A clinical diagnosis of dementia63 as determined by the investigator (Appendix 1). 5. A clinical diagnosis of Parkinson disease at the Screening visit as determined by the Investigator. 6. Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 7. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 8. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 9. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation. 10. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). 11. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).

Gender: Both
Minimum Age: 30 Years
Maximum Age: N/A
Healthy Volunteers: Accepts Healthy Volunteers

Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease

NCT ID: NCT01018264
Principal Investigator: Theresa Zesiewicz, MD

This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.

Condition:

Eligibility:

Inclusion Criteria: 1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria. 2. Age 40 years to 80 years. 3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry. 4. Patients must score 1.0 to 3.0 on the Modified Hoehn and Yahr scale. 5. Women of child-bearing potential must use a reliable method of contraception. 6. Must be experiencing symptoms of overactive bladder according to the ICS definition of a minimum voiding 8 or more times/24 hours and a daily average of at least 1 episode of urgency and/or urinary incontinence (urge incontinence predominately as measured by 3IQ diary) per 24 hours during a 3-day micturition diary period. Patients must have documentation of OAB within the last 6 months. 7. The patient must have evidence of PSA less than or equal to 4 (males only) within the last 12 months (obtained from primary care physician). 8. The patient must have had a bladder scan within six months of the screening visit. This scan uses ultrasound technology to measure residual fluid levels in the bladder after urination. This scan must document post void residual of 200 mls or less. A bladder scan printout or a note documenting these findings must be provided before baseline. 9. Clearance from the patient's internist or primary care health provider who has examined the patient within the last 6 months. Exclusion Criteria: 1. Any illness that in the investigator's opinion preclude participation in this study. 2. Pregnancy or lactation. 3. Concurrent participation in another clinical study. 4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam scores less than 27). 5. Legal incapacity or limited legal capacity. 6. History of prostate cancer or Transurethral resection of the prostate (TURP) (males only). 7. Presence of severe renal disease. BUN 50% greater than normal (normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L). Labs within the past 12 months will be requested from the patient's health care provider or urologist. If labs are not available within this time-frame or if results are abnormal, labs will be obtained as part of the screening visit. 8. Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis). 9. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone. 10. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders. 11. History of narrow angle glaucoma. 12. Patients who have undergone pelvic radiation at any time. 13. Currently taking any of the following medications: - Antiarrhythmics: flecainide (Almarytm, Apocard, Ecrinal, Flécaine), digoxin (Lanoxin, Digitek, Lanoxicaps) - Antipsychotics: thioridazine (Mellaril, Novorizadine, Thioril) - Tricyclic anti-depressants: amitriptyline (Elavil, Tryptanol, Endep, Elatrol, Tryptizol, Trepiline, Laroxyl), amoxapine (Asendin, Asendis, Defanyl, Demolox, Moxadil), clomipramine (Anafranil), desipramine (Norpramin, Pertofrane), imipramine (Antideprin, Deprenil, Deprimin, Deprinol, Depsonil, Dynaprin, Eupramin, Imipramil, Irmin, Janimine, Melipramin, Surplix, Tofranil), nortriptyline (Aventyl, Pamelor, Nortrilen), protriptyline (Vivactil), trimipramine (Stangyl, Surmontil, Rhotrimine) - Psychotropics: doxepin (Aponal, Adapine, Sinquan, Sinequan) - Anticholinergics/Antispasmodics: trihexyphenidyl (Artane, Aparkan), benztropine (Cogentin), oxybutynin (Ditropan, Ditropan XL, Lyrinel XL, Oxytrol), darifenacin (Enablex), emepronium, flavoxate (Urispas), meladrazine, propiverine, solifenacin (Vesicare), tolterodine (Detrol, Detrol LA), trospium (Sanctura) - Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRI): duloxetine (Cymbalta, Yentreve), Venlafaxine (Effexor, Effexor XR) - Arylalkylamines: pseudoephedrine (Sudafed) - Anti-androgen: bicalutamide (Casodex, Cosudex, Calutide, Kalumid), finasteride (Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo, Prosteride, Gefina, Finasterid IVAX), dutasteride (Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost), Zoladex (goserelin acetate), Eulexin (flutamide), Lupron (leuprolide acetate) - Antihypertensives: prazosin (Minipress, Vasoflex, Hypovase) - Estrogens (Menest, Premarin, Premarin IV) - Acetylcholinesterase inhibitors (rivastigmine (Exelon), galantamine, (Reminyl, donepezil (Aricept), Tacrine. - Memantine (Namenda) 14. Urinary obstruction in male PD patients as diagnosed by a urologist 15. Active urinary tract infection. 16. Patients with a history of chronic severe constipation (by self report)

Gender: Both
Minimum Age: 40 Years
Maximum Age: 80 Years
Healthy Volunteers: No

Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease

NCT ID: NCT00571285
Principal Investigator: Marian L Evatt, MD, MSc

A statement of the problem of interest Retrospective review of records in the Emory Movement Disorders clinic suggests vitamin D deficiency occurs in over 80% of patients with Parkinson's Disease (PD), much more frequently than in internal medicine clinics. Laboratory studies have suggested vitamin D could play a role in the development of PD. In addition, low vitamin D levels have been associated with slower walking speeds, worse memory and thinking, and depression.

Condition:

1. A statement of the problem of interest Retrospective review of records in the Emory Movement Disorders clinic suggests vitamin D deficiency occurs in over 80% of patients with Parkinson's Disease (PD), much more frequently than in internal medicine clinics. Laboratory studies have suggested vitamin D could play a role in the development of PD. In addition, low vitamin D levels have been associated with slower walking speeds, worse memory and thinking, and depression. 2. General statement of how the problem will be studied About 150 persons who have PD and low vitamin D levels will participate in this study. Subjects will be randomly (like flipping a coin) assigned to either high dose vitamin D supplement (54,200 IU weekly) or the Recommended Daily Allowance (RDA) for older persons (4200 IU weekly of vitamin D). Subjects will be examined in the clinic before, then 3- and 6- months after taking vitamin D supplement. Tests of walking speed, Parkinson's rating scales, memory tests and questionnaires of mood, anxiety and fatigue will be administered. 3. How the research will advance scientific knowledge and/or human health If this study confirms that vitamin D deficiency is occurs in 80% of patients, other patients may benefit because awareness of the problem will be increased. Also, this study will help determine whether vitamin D improves patients' functioning. 4. What the standard of care, if any, is Currently, there is no "standard of care" for persons with low vitamin D. At the VA Medical center providers use a variety of supplement regimens. The Institute of Medicine (IOM) has published 600 IU per day (4200 IU per week) as the Recommended Daily Allowance (RDA). By definition, the RDA is the amount of a vitamin or supplement that will prevent 97-98% of the population from becoming deficient.

Eligibility:

Inclusion Criteria: - Eligible participants must be able to provide informed consent or have a legal representative (defined by Georgia Law) who can give consent. - Diagnosis of IPD, based on history of 2/3 cardinal features of PD (tremor, bradykinesia and rigidity) and definite response to dopaminergic therapy. - Previous serum 25-OH vitamin D concentration measured by treating physician within previous 3 months. - Eligible participants must be able to complete the study questionnaires and assessments (e.g., participant must be judged able to complete TUG at screening/baseline). - Participants must be free of active cancer or other serious medical condition which might reasonably preclude their completing the 6-month intervention. - Participants must be able to complete an 8 meter walk at screening evaluation. Exclusion Criteria: - Patients with PD, H&Y stage I-IV will be eligible to participate in this study. - Participants must be ages 18-89 years. - Patient with a history of hypercalcemia, hypercalciuria, liver failure, end-stage renal disease (National Kidney Foundation Classification Stage 5) or kidney stones within the past 5 years will be excluded. - Specifically, potential participants with GFR (estimated or measured) <15 ml/min are excluded.

Gender: Both
Minimum Age: 18 Years
Maximum Age: 89 Years
Healthy Volunteers: No