NCT00162981

Clobazam in Subjects With Lennox-Gastaut Syndrome

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Lundbeck LLC · Industry
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment. More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.

Conditions

• Epilepsy
• Epilepsy, Generalized
• Seizures

Interventions

Type	Name	Description
DRUG	Clobazam Low Dose	5 to 10 mg/day with doses in the morning and at bedtime; orally
DRUG	Clobazam High Dose	5 to 40 mg/day with doses in the morning and at bedtime; orally

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-08-01
• Completion: 2006-10-01
• First posted: 2005-09-13
• Last updated: 2012-02-09
• Results posted: 2012-02-09

Locations

14 sites across 1 country: United States