Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

April 30, 2015

Conditions
Central Nervous System
Interventions
DRUG

perampanel

During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.

Trial Locations (23)

Unknown

Aurora

Washington D.C.

Gulf Breeze

Jacksonville

Miami

Orlando

Tampa

Augusta

Indianapolis

Lexington

Shreveport

Chesterfield

Columbia

Gibbsboro

Buffalo

Akron

Cincinnati

Philadelphia

Pittsburgh

Memphis

San Antonio

Salt Lake City

Richmond

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01527006 - Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs | Biotech Hunter | Biotech Hunter