A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Eisai

Status: Completed

Conditions: Generalised Tonic-Clonic Seizures; Idiopathic Generalized Epilepsy; Partial Onset Seizures

Treatments: Drug: Perampanel

Study type: Observational

Funder types: Industry

Identifiers

NCT04252846

E2007-M044-512

Details and patient eligibility

About

The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

Enrollment: 191 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of epilepsy
2. History of POS with or without SG or PGTCS associated with IGE
3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
4. Previously treated with 1 or 2 AEDs as monotherapy
5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency

Exclusion criteria

1. Episode(s) of status epilepticus within the past 6 months before Screening

2. Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)

3. Previous or current use of perampanel

   Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days

4. Hypersensitivity to perampanel or any of the excipients

Trial design

191 participants in 1 patient group

Perampanel

Description:

Participants with a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment.

Treatment:

Drug: Perampanel