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Clobazam in Patients With Lennox-Gastaut Syndrome

NCT00518713 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2012-02-09

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

Conditions

Interventions

DRUG

Clobazam Low Dose

0.25 mg/kg/day; tablets; orally; for 15-18 weeks

DRUG

Clobazam Medium Dose

0.5 mg/kg/day; tablets; orally; for 15-18 weeks

DRUG

Clobazam High Dose

1.0 mg/kg/day; tablets; orally; for 15-18 weeks

DRUG

Placebo

tablets; orally; daily for 15-18 weeks

Sponsors & Collaborators

  • Lundbeck LLC

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-12-31
Completion
2010-04-30

Countries

  • United States
  • Australia
  • Belarus
  • India
  • Lithuania

Study Locations

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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 NCT00518713 on ClinicalTrials.gov