A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic drugs.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
Enrollment: 307
Study Start Date: September 2011
Estimated Study Completion Date: April 2017
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: perampanel
- Placebo Comparator: placebo


Related journal: Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy: A randomized trial