Current Clinical Research Trials for Epilepsy

Researchers at The GW Medical Faculty Associate’s Epilepsy Center are conducting clinical research trials to learn more about treating epilepsy, or seizure disorders. 

Clinical research trials search for new ways to prevent, understand and/or treat disease. The goal of these trials is to see if a new treatment, procedure or device works and is safe to use.  Participating in a research trial, as either a healthy volunteer or a patient volunteer, is an opportunity to help researchers find better treatments for others in the future.

The following are clinical research trials specific to epilepsy:

 

DBS: Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE) 

Principal Investigator: Mohamad Koubeissi, M.D.

Status of Research Trial: Active, currently recruiting

Sponsor of Research Trial: Medtronic and The George Washington University

Description of Research Trial: The primary aim of the current proposal is to evaluate safety and tolerability, in terms of neuropsychological effects, of low frequency electrical stimulation of the fornix (LFSF) in participants with medically-intractable MTLE. Secondary aims include evaluation of psychiatric changes, seizure frequency, and quality of life during LFSF.

Research Trial Contact Information:  For more information, interested participants and clinicians may contact the Neurology Clinical Research Unit at neurostudies@mfa.gwu.edu.

 

101EP201

Principal Investigator: Mohamad Koubeissi, M.D.

Title of Research Trial: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab as Adjunctive Therapy in Adult Subjects with Drug-Resistant Focal Epilepsy

Status of Research Trial: Not yet active

Sponsor of Research Trial: Biogen

Description of Research Trial: The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.

Research Trial Contact Information:  For more information, interested participants and clinicians may contact the Neurology Clinical Research Unit at neurostudies@mfa.gwu.edu.

 

ENGAGE-E-001

Principal Investigator: Anumeha Sheth, M.D.

Title of Research Trial: A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam in Subjects with Epilepsy with a Predictable Seizure Pattern

Status of Research Trial: Not yet active

Sponsor of Research Trial: Engage Therapeutics, Inc.

Description of Research Trial: This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with epilepsy with a predictable seizure pattern. These subjects have an established diagnosis of focal or generalized epilepsy with a documented history of predictable seizure episodes. This is an in-patient study. The subjects will be admitted to the Epilepsy Monitoring Unit (EMU) for study participation. The duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject will be treated with study medication. The duration and timing of the seizure event and occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through clinical observation and confirmed with video electroencephalogram (EEG). 

Research Trial Contact Information:  For more information, interested participants and clinicians may contact the Neurology Clinical Research Unit at neurostudies@mfa.gwu.edu.