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A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents

NCT01161524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2019-05-15

Study results available
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Summary

This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.

Conditions

Interventions

DRUG

Perampanel

2 mg titrated up to 8-12 mg maximum; taken once daily.

DRUG

Placebo

Matching Placebo taken once daily.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Haichen Yang, M.D., M.A. · Study Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-06-30
Completion
2014-11-30

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • Hungary
  • India
  • Latvia
  • Poland
  • South Korea
  • Spain
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01161524 on ClinicalTrials.gov