NCT00162981

Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome

Completed Phase 2 Results posted Last updated 6 January 2012

What this trial tests

Phase 2 trial testing Clobazam Low Dose in Epilepsy in 68 participants. Completed in 1 October 2006.

Timeline

1 October 2005

Primary endpoint
1 August 2006

1 October 2006

Quick facts

Lead sponsor	Lundbeck LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	68
Start date	1 October 2005
Primary completion	1 August 2006
Estimated completion	1 October 2006
Sites	14 locations across United States

Drugs / interventions tested

• Clobazam Low Dose — full drug profile →
• Clobazam High Dose — full drug profile →

Conditions studied

• Epilepsy — all drugs for Epilepsy →
• Epilepsy, Generalized — all drugs for Epilepsy, Generalized →
• Seizures — all drugs for Seizures →

Sponsor

Lundbeck LLC — full company profile →

Who can join

Adults 2 to 30, any sex, with Epilepsy or Epilepsy, Generalized. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percent Reduction in Number of Drop Seizures.
  Time frame: 4-week baseline period and 4-week maintenance period
  Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
• A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.
  Time frame: 4-week baseline period and the 4-week maintenance period
  Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.

Sponsor's own description

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 subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Stable dosages of clobazam for Lennox-Gastaut syndrome are associated with sustained drop-seizure and total-seizure improvements over 3 years.
   Conry JA, Ng YT, Kernitsky L, Mitchell WG, et al · · 2014 · cited 34× · PMID 24580023 · DOI 10.1111/epi.12561