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Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

NCT02834793 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2022-03-09

Study results available
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Summary

This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS).

Conditions

  • Lennox-Gastaut Syndrome (LGS)

Interventions

DRUG

Placebo

Participants will receive matching placebo in Randomization phase.

DRUG

Perampanel

Participants will receive perampanel in Randomization phase, open-label Extension A, and open-label Extension B.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-13
Primary Completion
2021-05-26
Completion
2021-07-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • India
  • Japan
  • South Korea

Study Locations

More Related Trials

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 NCT02834793 on ClinicalTrials.gov