Skip Navigation

Epilepsy Clinical Trials

SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy

NCT ID: NCT00101933

The purpose of this research is to study the safety and effectiveness of bilateral stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications.

Condition:

Medtronic, Inc. is sponsoring an investigational study of the Medtronic DBS Therapy for epilepsy, the company's deep brain stimulation (DBS) therapy for patients with refractory epilepsy. Epilepsy is a condition that affects 2.3 million Americans, and about one-third of these patients are refractory, or continue to experience seizures despite a wide range of treatment options. The prospective, randomized, double-blind trial uses existing technology to test whether bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively reduce seizure frequency in patients with epilepsy. It includes enrollment of 157 patients at 17 sites in the U.S. 110 patients were implanted and monitored for 13 months following implant, with long-term follow-up until the device is approved or the study is stopped. 109 of the 110 implanted subjects were randomized to Active stimulation or Control. Patients in the active group, who received neurostimulation, were monitored for a reduction in seizure rates compared to the control group, who did not receive neurostimulation during the three-month double-blind phase. After the double-blind phase, all patients received neurostimulation. Candidates for the trial were adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. They were to have had an average of six or more seizures per month. Candidates continued to receive their epilepsy medications while participating in the trial. Deep brain stimulation therapy has already received approval in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Deep brain stimulation is not approved in the United States for the treatment of epilepsy.

Eligibility:

Relevant Inclusion and Exclusion Criteria are listed below. Inclusion Criteria - Partial-onset seizures with or without secondary generalization. The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video/clinical EEG that captured at least one ictal event. - Anticipated average of 6 or more partial-onset seizures (with or without secondary generalized seizures) per month during the Baseline Phase, with no more than 30 days between seizures during the Baseline Phase. - Refractory to antiepileptic drugs (AEDs). Patients will be considered refractory if they have failed at least three AEDs due to lack of efficacy. - Receiving one to four currently marketed AEDs - Be between 18 and 65 years of age at the time of lead implant Exclusion Criteria: - Multilobar (>3 different lobes) anatomic areas of seizure onset - Symptomatic generalized epilepsy - Previous diagnosis of psychogenic/non-epileptic seizures - Presence of implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemakers, spinal cord stimulator) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators are allowed if the device has been turned off for at least 30 days prior to the Baseline Week -12 visit and the patient agrees to have the generator explanted prior to or at the time of the Kinetra Neurostimulator implant.

Gender: Both
Minimum Age: 18 Years
Maximum Age: 65 Years
Healthy Volunteers: No

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

NCT ID: NCT01545518
Principal Investigator: Charles M. Epstein, M.D.

The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG). The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG. At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

Condition:

The study is divided into two phases: Phase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. This part of the study involves obtaining a single blood sample, equal to about 2 teaspoons. Phase 2: If a sufficient number of cases are identified, a double-blind crossover study of IVIG treatment will be performed in these patients.

Eligibility:

Inclusion Criteria: - Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months. - Age 18 to 50. - Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy. - Refractory to an adequate trial of two or more main-line anti-epileptic drugs. - Ability to keep a seizure diary. - Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the exception of hippocampal sclerosis Exclusion Criteria: - History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects. - Evidence of psychogenic epilepsy. - History of convulsive status epilepticus. - History of primary generalized epilepsy in a first degree relative. - Known serious medical illness.

Gender: Both
Minimum Age: 18 Years
Maximum Age: 50 Years
Healthy Volunteers: No

Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

NCT ID: NCT01118962

The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.

Condition:

Eligibility:

Inclusion Criteria: - Subject completed the SP0961 (NCT01118949) study - Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator Exclusion Criteria: - Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)

Gender: Both
Minimum Age: 16 Years
Maximum Age: 65 Years
Healthy Volunteers: No

Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated

NCT ID: NCT01281293
Contact: Mark Bunker, PharmD, 281-228-7223

Vagal Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy since 1994. This post-market study is designed to follow the clinical course and outcomes for patients with refractory seizures treated with adjunctive VNS Therapy. Seizure frequency, seizure severity, side effects burden, depressive symptoms, global impressions, and health care utilization will be evaluated. The results of this study will provide data to guide physicians and their patients in the use of VNS Therapy for patients with refractory seizures who have failed initial trials of anti-epileptic drug (AED) therapy. The data being collected is not for the purposes of confirmatory assessment.

Condition:

Minimum ages eligible for the E-103 study is at least 7 years outside of the US, consistent with "Non-US" labeling and 12 years for sites in the US.

Eligibility:

Inclusion Criteria: Patients enrolled in the study must meet all of the following criteria at Visit 1: (Baseline) if Screening Incl/Excl is omitted: 1. Patients must agree to be treated with VNS Therapy. The decision to treat with VNS Therapy must have been made independent of and prior to participation in the study. 2. Patients participating at Sites not located in the US must follow the "Non-US" labeling and be at least 7 years or older and whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications; patients participating at Sites located in the United States must be 12 years or older and have partial onset seizures or must follow the indication for use statement (for VNS Therapy) in the country of origin. 3. Patient and/or caregiver must be able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance. 4. Patient or legal guardian understands study procedures and voluntarily signs an informed consent and in the United States a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event that the patient is under the age of 18 the patient will also be required to sign an assent affirming their agreement to participate in research according to local IRB requirements. Similar authorization is required per EC requirements, or equivalent authority. Additional Continuation Criteria to be evaluated at Visit 2 (Baseline): 5. Patient must be taking at least 1 anti-epileptic drug treatment and stable on said medications for at least 8 weeks (56 days) prior to baseline. (Rescue medication may be allowed on a case-by case basis with Cyberonics approval.) 6. Patient must have a minimum frequency of 3 seizures (excluding absence seizures, simple partial seizures and myoclonic jerks) per month (average over 2 months) prior to baseline; maximum frequency is 20 seizures per day. 7. Patient must have no more than 4 weeks between seizures (over 2 months) prior to baseline. Exclusion Criteria: Patients with any of the following will not be eligible for enrollment: 1. Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. 2. Patient is expected to require full body magnetic resonance imaging during the clinical study. 3. Patient has a progressive neurological condition (e.g. brain tumor etc.). 4. In the investigator's opinion, the inability of the patient, legal guardian or reluctance of the child to comply with the frequency of clinic visits during the treatment phase. 5. In the investigator's opinion, the patient has a history of noncompliance for seizure diary completion. 6. Patient is currently using an investigational device or pharmacologic medication not approved by either EU or US regulatory authority. 7. Patient has had a previous VNS Therapy implant. 8. In the investigator's opinion, the patient is suicidal.

Gender: Both
Minimum Age: 7 Years
Maximum Age: N/A
Healthy Volunteers: No

Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects

NCT ID: NCT01530022

The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.

Condition:

Approximately 50 subjects at multiple sites will crossover to receive both treatments (lacosamide [LCM]and carbamazepine immediate release [CBZ-IR]) in a randomized order during the 2 study treatment periods (Treatment Period 1 and Treatment Period 2). A Screening Visit will be conducted to evaluate subject eligibility for enrollment into the study. Eligible subjects will return up to 21 days after the Screening Visit and begin Treatment Period 1. During Visit 2, eligible subjects will be randomized to receive either LCM 300 mg/day or CBZ-IR 600 mg/day. Subjects will be treated with their first randomized Antiepileptic Drug (AED) for 6 weeks (Titration Period [21 days] and Maintenance Period [21 days]). Subjects then complete a 28-day Taper/Washout Period, during which their first AED will be tapered over 4 days followed by a 24-day Washout Period, where subjects will receive no AED. Upon completion of the Taper/Washout Period, subjects will begin Treatment Period 2.The procedures and assessments for Treatment Period 1 will be repeated for Treatment Period 2 (with the same duration of treatment).

Eligibility:

Inclusion Criteria: - Subjects are between 18 and 55 years of age (inclusive) - Subjects have a Body Mass Index (BMI) between 18 and 35 kg/m^2 (inclusive) - Subjects must be in generally good health with no clinically relevant health conditions Exclusion Criteria: - Subject has previously been randomized in this study or subject has received LCM or CBZ - Subjects may not currently be participating in or have participated in the past 30 days in a clinical drug or device study - Subjects may not have a history of drug or alcohol abuse within the last 2 years - Subjects may not consume more than 40 g of alcohol per day - Females who are pregnant or nursing are ineligible; females of childbearing potential must agree to adhere to protocol conception guidelines - Subjects may not score ≤ 70 on the Peabody Picture Vocabulary Test (PPVT) - Subjects with a lifetime history of suicide attempt or suicidal ideation in the past 6 months may not participate - Subjects with a diet that deviates notably from the normal amounts of protein, carbohydrate, and fat, as judged by the investigator are ineligible to participate - Subjects may not consume more than 600 mg of caffeine/day - Subjects may not smoke more than 10 cigarettes per day or have done so within 6 months prior to Screening - Subjects may not have a positive alcohol breath test or urine drug screen at Screening

Gender: Both
Minimum Age: 18 Years
Maximum Age: 55 Years
Healthy Volunteers: Accepts Healthy Volunteers

Treatment Trial for Psychogenic Nonepileptic Seizures

NCT ID: NCT00835627
Principal Investigator: W. Curt LaFrance, Jr., MD, MPH

The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES) compared to patients who receive community care / treatment as usual (TAU). The purpose of this study is to provide pilot testing and data to inform the future multicenter randomized controlled trial based on the hypothesis.

Condition:

This is a pilot, prospective, multi-center, randomized controlled trial, that assesses the number of NES in patients treated with either flexible dose sertraline (Zoloft), cognitive behavioral therapy-informed psychotherapy (CBT-ip), combined therapy (sertraline + CBT-ip) or community care (treatment as usual TAU). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Secondary objective variables include reduction in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning. After being diagnosed with NES by video EEG monitoring (vEEG), up to 40 participants will be enrolled and monitored during a two week lead in period for their baseline NES and psychosocial symptoms and functioning. At week 2, they will be randomized to either: flexible dose sertraline (25 to 200mg), CBT, CBT+med, or to the control arm, TAU. Participants randomized to the sertraline arm will be titrated over 6 weeks up to 200mg or to dose limited by side effects. The subjects will stay on their maximum fixed dose for the next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can taper off the medication over the final two weeks of the treatment trial. Those randomized to the CBT-ip arm will receive 12 weekly sessions of CBT-ip for NES. Those randomized to the CBT-ip + med arm will receive both treatments. Those randomized to the TAU arm will follow with their treatment providers. After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and 12 after enrollment to assess seizure status, medication usage, and global functioning. Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and function scales. They will keep a seizure diary to evaluate their daily seizure activity.

Eligibility:

Inclusion Criteria: - Video electroencephalogram (EEG) confirmed diagnosis of NES - Have at least one nonepileptic seizure per month - Able to complete self report symptom scales - Not receiving optimized sertraline Exclusion Criteria: - Equivocal EEG findings - using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan - allergy/sensitivity to sertraline - current alcohol/drug dependence - serious medical illness requiring current hospitalization

Gender: Both
Minimum Age: 18 Years
Maximum Age: 95 Years
Healthy Volunteers: No

Lamotrigine Extended-Release In Elderly Patients With Epilepsy

NCT ID: NCT00516139

This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.

Condition:

Eligibility:

Inclusion criteria: - Confident diagnosis of epilepsy - Currently treated with one or two antiepileptic medications - Able to complete a seizure diary Exclusion criteria: - History of hypersensitivity to lamotrigine - Progressive diseases that would interfere with the study objectives

Gender: Both
Minimum Age: 65 Years
Maximum Age: N/A
Healthy Volunteers: No