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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00699972 |
The purpose of this study is to determine whether perampanel when given as an adjunctive therapy in subjects with refractory partial seizures is effective at changing the frequency of seizures.
Condition | Intervention | Phase |
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Refractory Partial Seizures |
Drug: E2007 (Perampanel) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures |
Estimated Enrollment: | 375 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: E2007 (Perampanel)
8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm.
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2: Experimental |
Drug: E2007 (Perampanel)
12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm.
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3: Placebo Comparator |
Drug: Placebo
Placebo in a 1:1:1 ratio, 125 subjects/arm.
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Subjects who enter the Titration Period (six weeks) of the Double-Blind Phase of the study will be randomized to receive Perampanel or placebo. All subjects will take a maximum of six tablets daily for the duration of the study. Subjects will be up-titrated weekly in 2 mg increments to their randomized dose (8 mg, 12 mg or placebo). Subjects will enter the Maintenance Period (12 weeks) on the Perampanel dose achieved during the Titration period and continue study drug once daily in a blinded fashion.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Each subject must meet all of the following criteria to be enrolled in this study:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
Contact: Eisai Medical Services | 1-888-422-4743 |
Study Director: | David Squillacote, M.D. | Eisai Medical Research Inc. |
Responsible Party: | Eisai Medical Research Inc. ( David Squillacote, M.D. ) |
Study ID Numbers: | E2007-G000-304 |
Study First Received: | June 17, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00699972 |
Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
E2007 perampanel refractory partial seizures adjunctive therapy |
seizure frequency reduction in seizure frequency safety concomitant AED(s) |
Signs and Symptoms Epilepsy Seizures |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Nervous System Diseases |