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Sponsors and Collaborators: |
Eisai Medical Research Inc. Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00416195 |
This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each. One group will be patients who take concomitant inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to a maximum of 12 mg per day) and six will receive placebo.
Condition | Intervention | Phase |
---|---|---|
Epilepsy |
Drug: E2007 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Explore the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures |
Enrollment: | 48 |
Study Start Date: | December 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
Latvia | |
P. Stradina Clinical University Hospital | |
Riga, Latvia, LV-1002 | |
Hospital Gailezers | |
Riga, Latvia, LV-1038 |
Study Director: | Julia Yang, MD, MBA | Eisai Medical Research Inc. |
Study ID Numbers: | E2007-G000-208 |
Study First Received: | December 26, 2006 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00416195 |
Health Authority: | European Union: European Medicines Agency |
Epilepsy Seizures Central Nervous System Diseases Brain Diseases |
Nervous System Diseases |