Ongoing Federal Support

Neuroimaging Core of Early Randomized Surgical Epilepsy Trial (ERSET) (NIH (Panel ZNS1 SRB-K)

P.I.: T.Henry. Dates: 05/01/02 ˆ 04/30/07
Goals: Analysis of MRI and interictal FDG PET studies obtained from 15 clinical centers for the larger ERSET project, to support clinical applications of imaging in ERSET, and to test hypotheses regarding progression in focal atrophies and metabolic dysfunction in temporal lobe epilepsy patients who have ongoing seizures versus those who become seizure-free. The ERSET project (overall P.I. J.Engel, Jr., UCLA) is a prospective, randomized clinical trial of early anterior temporal lobectomy versus prolonged medical management of medically refractory temporal lobe epilepsy.
T.Henry: Primary responsibility for formulating hypotheses and designing data acquisition and analysis of MRI and FDG PET studies, at all sites. Additional responsibilities of assisting with overall study planning and planning for Emory site involvement.

Ongoing Non-Federal Support

Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (SANTE) (Sponsor: Medtronic, Inc., Minneapolis, MN)

P.I.: T. Henry (Emory site) Dates: 04/01/04 ˆ 03/31/06
Goals: Phase II study of chronic, intermittent, high-frequency electrical stimulation of the anterior thalamic nuclei bilaterally in patients with refractory, partial epilepsies.
T.Henry: Primary responsibility at Emory site for assuring patient safety and obtaining IRB approval, patient diagnosis and recruitment, clinical epilepsy care, clinical data acquisition, neuroimaging data acquisition and analysis, and study administration.

Pregabalin BID Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Safety and Efficacy in Patients With Partial Seizures (Sponsor: Pfizer, Inc., New York, NY)

P.I.: T. Henry (Emory site) Dates: 11/02/98 ˆ 11/01/05
Goals: Multicenter, open-label trial of adjunctive pregabalin therapy in refractory partial epilepsy, as follow-on to multicenter, double-blind, placebo-controlled, randomized Phase III trials of adjunctive pregabalin therapy in refractory partial epilepsy.
T.Henry: Responsibilities at Emory site for assuring patient safety and obtaining IRB approval, patient diagnosis and recruitment, clinical epilepsy care, clinical data acquisition, and study administration.

Completed Federal Support

Diagnostic Neuroactivation PET Studies (NIH FIRST Award)

P.I.: J. Votaw Dates: 04/01/95 ˆ 03/31/00
Goals: Development of techniques for cerebral blood flow imaging with positron emission tomography for stimulation in patients with complex partial seizures.
T.Henry: Responsibilities included formulation of hypotheses and project design, patient diagnosis and recruitment, data acquisition, and data analysis.

Planning Grant: Multicenter Randomized Trial on Early Surgical Intervention for Mesial Temporal Lobe Epilepsy (NIH (Panel ZNS1 SRB-W1)

P.I.: J. Engel, Jr. Dates: 07/01/99 ˆ 06/30/00
Goals: Prospective, randomized clinical trial of early anterior temporal lobectomy versus prolonged medical management of medically refractory temporal lobe epilepsy.
T.Henry: Primary responsibility for formulating hypotheses and designing data acquisition and analysis of MRI and FDG PET studies, at all sites. Assisting with overall study planning and planning for Emory site involvement.

A Test of an Epilepsy Self-Management Model (NIH - 1 R01 NR04770-01)

P.I.: C. DiIorio Dates: 07/01/99 ˆ 06/30/02
Goals: Testing hypotheses concerning self-management of epilepsy as it changes over time, using a detailed questionnaire and interview, in the Emory Epilepsy Center patient population.
T. Henry: Responsibilities include formulation of hypotheses and project design, patient diagnosis and recruitment, and data analysis.

Completed Non-Federal Support

Serum and Erythrocyte Membrane Fatty Acid Levels in Epilepsy (Sponsor: Leon Bender Epilepsy Research Foundation, Atlanta, GA)

P.I.: T. Henry Dates: 09/26/01 ˆ 09/25/04
Goals: Determining plasma and erythrocyte membrane levels of docosahexaenoic acid, eicosapentaenoic acid, and arachidonic acid in patients with epilepsy, for support of a pilot trial of refined menhaden oil supplementation.

T.Henry: Primary responsibility for formulating hypotheses, designing data acquisition, assuring patient safety and obtaining IRB approval, patient diagnosis and recruitment, data analysis, and study administration.

Summary of industry-sponsored studies completed within the last 3 years:

Single-center studies of epilepsy therapeutic mechanisms of action, in which Dr. Henry participated as P.I.:
Fluoro-dopa PET studies of vagus nerve stimulation in partial epilepsy (Cyberonics, Inc.).

Multicenter studies of epilepsy therapies, in which Dr. Henry participated as Emory site P.I.:
A Pilot Short-Term Safety and Feasibility Study of Implanting GABA-Producing Porcine Fetal Neuronal Cells into Epileptogenic Tissue of Patients with Focal Epilepsy with Single or Multiple Epileptogenic Sites in the Temporal and/or Frontal Lobes, Phase I (Sponsor: Diacrin, Inc., Charlestown, MA)

Pregabalin in partial epilepsy, Phase II (Pfizer, Inc.).

Rufinamide in partial epilepsy, Phase II (Novartis, Inc.).

Zonisamide in partial epilepsy, Phase III (Elan, Inc.).

Topiramate vs. valproate in juvenile myoclonic epilepsy, Phase III (Ortho-McNeil, Inc.)

Multicenter studies of epilepsy therapies, in which Dr. Henry participated as Emory site Co-Investigator:
Levetiracetam in partial epilepsy, Phase II (Emory site P.I.: P.Pennell; UCB Pharma, Inc.).

Oxcarbazepine in partial epilepsy, Phase II (Emory site P.I.: P.Pennell; Novartis, Inc.).

Parenteral monohydroxy-derivative of oxcarbazepine in partial epilepsy, Phase II (Emory site P.I.: P.Pennell; Novartis, Inc.).