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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00144690 |
The primary objective of this study is to determine the maximal tolerated dose (MTD) of E2007 given twice daily (bid) or once a day (qd) in patients with refractory partial-onset seizures (including secondarily generalized seizures). The secondary objectives are to evaluate the safety, efficacy, concentration-efficacy relationship, and pharmacokinetics of E2007 and the effects of E2007 on the Profile of Mood States (POMS) test.
Condition | Intervention | Phase |
---|---|---|
Epilepsy |
Drug: E2007 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures |
Study Start Date: | March 2005 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Dept. of Neuro Surgery | |
Little Rock, Arkansas, United States, 72205 | |
United States, Florida | |
USF Physicians Group | |
Tampa, Florida, United States, 33606 | |
United States, Michigan | |
Clinical Trials | |
Detroit, Michigan, United States, 48202 | |
United States, Ohio | |
Medical College of Ohio Comprehensive Epilepsy Ctr. | |
Toledo, Ohio, United States, 43614 | |
United States, Tennessee | |
Vanderbilt University Medical Ctr. | |
Nashville, Tennessee, United States, 37212 |
Study Director: | Santiago Arroyo, M.D., Ph.D. | Eisai Medical Research Inc. |
Study ID Numbers: | E2007-A001-206 |
Study First Received: | September 1, 2005 |
Last Updated: | July 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00144690 |
Health Authority: | United States: Food and Drug Administration |
Epilepsy refractory partial seizures |
Epilepsy Seizures Central Nervous System Diseases Brain Diseases |
Nervous System Diseases |