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Clinical trial

A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

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Last updated:31st May 2019
Identifier: NCT04015141

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

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