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Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

NCT00700310 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 712

Last updated 2016-01-21

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Conditions

  • Refractory Partial Seizures

Interventions

DRUG

perampanel

2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

DRUG

perampanel

4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

DRUG

perampanel

8 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

DRUG

Placebo

Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • David Squillacote, M.D. · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-08-31
Completion
2010-01-31

Countries

  • Australia
  • Bulgaria
  • Czechia
  • Estonia
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

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Entities

Drugs

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 NCT00700310 on ClinicalTrials.gov