A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
E2007-G000-332 EXT
Study Overview
E2007
perampanel
NCT01393743, EU CTR 2011-000265-12
Sep 2011 - May 2014
Primary Generalised Tonic Clonic Seizures
The primary efficacy endpoint was the percent change from baseline in PGTC seizure frequency per 28 days during treatment (Titration and Maintenance Periods combined), except for the purpose of European Union (EU) registration. The primary efficacy endpoint for the purpose of EU registration was the 50% responder rate (50% or greater reduction in PGTC seizure frequency during Maintenance Period relative to baseline).
Males and females (age 12 and over)
Completed
Phase
3
Australia, Austria, China, Czech Republic, Estonia, France, Germany, Greece, Hungary, India, Israel, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, Poland, Serbia, United States See moreSee less
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The clinical trial lay summaries contained on this website are from clinical trials sponsored by Eisai and are provided for informational purposes only. These summaries contain data from the specific study population but do not include the patient-level data from each study participant. The results reported in any single trial may not reflect the overall potential risks or benefits associated with Eisai’s products.
Only health care professionals may determine if a specific product is appropriate as a treatment option for a particular patient. Health care professionals should refer to the specific labelling information approved in their country when making prescribing decisions.
The information provided is not intended to commercialize or promote Eisai’s products for any unapproved uses.
All reasonable precautions have been taken to ensure the accuracy, security and confidentiality of information contained on this website. Eisai reserves the right to amend any information on this website at any time at its sole discretion.
If you have questions about the results, please speak with the doctor, research nurse, or other team member at your trial site.
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Wechsler et al (2016) Long-term Safety and Efficacy of Adjunctive Perampanel in Patients with Drug-resistant Primary Generalised Tonic-clonic Seizures in Idiopathic Generalised Epilepsy: Results of an Open-label Extension. Poster presented at the 12th European Congress on Epileptology, Prague, Czech Republic, 11–15 September 2016 (P555)
Data Sharing
ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.
Redacted documents are available upon request for this study.