Perampanel as first add-on in epilepsy therapy: an observational study
Research type
Research Study
Full title
A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel when Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects ≥12 Years with Partial Onset Seizures With or Without Secondary Generalization or with Primary Generalized Tonic–Clonic Seizures Associated with Idiopathic Generalized Epilepsy
IRAS ID
279511
Contact name
Craig Heath
Contact email
Sponsor organisation
Eisai Europe Ltd
Duration of Study in the UK
1 years, 11 months, 22 days
Research summary
This is an observational study, which will not include any interventional procedures. The aim of the study is to measure retention rate (how many participants continue to take perampanel) over 12 months. It will enrol 300 participants with a diagnosis of epilepsy (partial onset seizures with or without secondary generalization, or primary generalized tonic– clonic seizures associated with idiopathic generalized epilepsy), for whom the treating physician has made the decision to prescribe perampanel, in addition to their baseline anti-epileptic drug.
Participants for the study will be identified by sites when they attend their normal epilepsy clinic appointment, or from their electronic or paper medical and pharmacy records. The clinical decision to prescribe perampanel will already have been made before the participant is identified for the study (i.e. the decision to prescribe perampanel is independent of the decision to enrol the subject in the study). Participants will be seen as determined by the treating physician and according to usual clinical practice.
The study team at site will collect data by reviewing the medical records of the participant, their seizure diaries, and information from interviews held with the participant or their caregivers at clinic visits.
The study will be conducted at approximately 40 epilepsy and neurology centre sites. Participants will be seen at a baseline (study start) visit and then according to usual clinical practice, but a visit will be included at approximately 6 months (±4 weeks) and approximately 12 months (±8 weeks). Data from visits at other times will be recorded and analysed (if feasible). If the participant does not want to take part in the study any more, or stops taking perampanel, data from the final assessment will be collected (if available).
REC name
London - Brent Research Ethics Committee
REC reference
20/PR/0591
Date of REC Opinion
21 Jan 2021
REC opinion
Further Information Favourable Opinion