A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy
Actual Study Start Date: May 31, 2019
Estimated Primary Completion Date: October 13, 2021
Estimated Study Completion Date: June 30, 2022
Arm:
- Experimental: Perampanel
Category | Value |
---|---|
Date last updated at source | 2019-07-10 |
Study type(s) | Interventional |
Expected enrolment | 100 |
Study start date | 2019-05-31 |
Estimated primary completion date | 2021-10-13 |