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Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
Details
| Lead sponsor | Eisai Inc. |
|---|---|
| Phase | PHASE4 |
| Status | COMPLETED |
| Enrolment | 54 |
| Start date | Wed Aug 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Apr 27 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Partial Onset Seizures
- Secondarily Generalized Seizures
- Primary Generalized Tonic-Clonic Seizures
Interventions
- Perampanel
Countries
United States