At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 267 enrolled

Drug / intervention

Clobazamdrug

Likely dose

Clobazam 5 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01160770

NCT01160770Phase 3Completed

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Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

Lundbeck LLC·interventional·Posted Jul 12, 2010·Updated Mar 21, 2018

In Brief

A Phase 3 clinical trial evaluating Clobazam for Lennox-Gastaut Syndrome. Completed, enrolled 267 participants.

Detailed Summary

The objective of this study is to evaluate the long-term safety and effectiveness of open-label clobazam in the treatment of drop seizures in subjects with LGS.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLennox-Gastaut Syndrome

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2005

First PostedJul 2010

Primary CompletionFeb 2012

TodayJul 2026

First PostedJul 12, 2010

Enrollment StartDec 1, 2005

Primary CompletionFeb 1, 2012

TodayJul 2, 2026

Enrollment to primary: 6.2 yearsPosted 16.0 years ago

Interventions

Clobazamdrug

Clobazam will be provided in 5 mg, 10 mg and 20 mg tablets and will be dispensed in bottles as needed at each visit. Bottles may be dispensed between visits if necessary. Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must maintain the dose level for 48 hours. After the first 48 hours of the treatment period, investigators will be able to increase, decrease or maintain the subject's dose, up to an approximate maximum daily dose of 2.0 mg/kg (maximum dose of 80 mg/day).