Post Authorisation Safety Study of Perampanel in Epilepsy
Research type
Research Study
Full title
A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa® (Perampanel) as Add-on Therapy in Epilepsy Patients Aged = 12 Years
IRAS ID
132138
Contact name
Kathleen White
Contact email
Sponsor organisation
Eisai Limited
Research summary
This is a post-marketing observational safety to assess the safety and tolerability of Fycompa® (perampanel) as add-on therapy in epilepsy patients aged ≥ 12 Years. The study is funded by Eisai.\n\nFycompa was approved for use on 24 May 2012 by the Committee for Medicinal Products for Human Use (CHMP). As part of the approval the CHMP has requested Eisai to conduct a post-authorisation safety study as a source of additional safety data for identified safety risks and missing safety information. Therefore, this study has been designed as an observational, cohort study to evaluate the safety profile of perampanel when prescribed as add-on therapy in patients with epilepsy, to assess these adverse events under conditions of common (real-life) use in the epilepsy population.\n\nApproximately 500 subjects will be observed for approximately 52 weeks. About XX subjects will be recruited in the UK.\n\nPatient’s whose doctor has decided to prescribe Fycompa and who meets the inclusion/exclusion criteria will be considered for enrolment. If the patient consents to take part in the study they will have a screening visit and will be asked to visit their doctor on a regular basis, the frequency will be decided by the treating doctor as part of standard care (recommended at least every 6 months) for approximately 52 weeks. There will be an End of Study Visit at Week 52. For patients who discontinue the study or study drug prior to Week 52, there will be an Early Termination Visit and Follow-up Visit 2 weeks later.\n\nThis study involves procedures including: Medical/epilepsy history, concomitant medications and adverse events, questionnaires
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/0094
Date of REC Opinion
4 Apr 2014
REC opinion
Further Information Favourable Opinion