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Sponsored by: |
Eisai Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00699582 |
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial 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: | May 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | September 2011 (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. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
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2: Experimental |
Drug: E2007 (perampanel)
12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
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3: Placebo Comparator |
Drug: Placebo
Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.
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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:
(Note: the use of intermittent rescue benzodiazepines is defined in the exclusion criterion #22 below.) When used in these cases (epilepsy, anxiety or sleep disorders), benzodiazepines will be counted as 1 AED; therefore, only 1 or a maximum of 2 additional approved AEDs will be allowed. 12. A vagal nerve stimulator (VNS) is allowed but it must have been implanted ≥5 months prior to Visit 1.
Stimulator parameters can not be changed for 1 month (or no less than 21 days) prior to Visit 1 or thereafter during the 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-G000-305 |
Study First Received: | June 17, 2008 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00699582 History of Changes |
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 partial onset seizures safety concomitant AED(s) |
Signs and Symptoms Epilepsy Seizures |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Signs and Symptoms Epilepsy Nervous System Diseases Seizures |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases |