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

NCT01393743 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2017-08-28

Study results available
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Summary

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 (AED).

Conditions

  • Seizure Disorder Generalized Tonic Clonic

Interventions

DRUG

Perampanel

DRUG

Placebo comparator

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Francesco Bibbiani · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-05-31
Completion
2015-11-30

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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 NCT01393743 on ClinicalTrials.gov