Retrospective study to evaluate the safety of Perampanel in Epilepsy
Research type
Research Study
Full title
A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy
IRAS ID
204329
Contact name
Josemir W. Sander
Contact email
Sponsor organisation
Eisai Ltd.
Duration of Study in the UK
0 years, 1 months, 19 days
Research summary
This is a non-interventional retrospective data collection study to investigate the dosage, efficacy and safety of perampanel given as monotherapy in routine clinical care in patients with epilepsy.
Perampanel was approved for use as an adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients from 12 years of age with epilepsy and adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.
According to the "Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders” (CHMP/EWP/566/98 Rev.2/Corr) from the European
Medicines Agency (EMA), the availability of data regarding the conversion of perampanel from adjunctive therapy to monotherapy would be informative for patient management and useful to include in the Summary of Product Characteristics (SmPC) for perampanel.Historical data will be extracted from medical records (including seizure diaries) for patients who have epilepsy and treated with perampanel as primary or secondary (conversion to) monotherapy.
Approximately 100 patients are expected to be obtained from the medical records of 40 epilepsy centres in Europe.
All patients will only have retrospective(looking back in time) data collection.
There are no study procedures associated with this study.
The study is funded by Eisai Inc.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0187
Date of REC Opinion
9 May 2016
REC opinion
Favourable Opinion