Clobazam in Subjects With Lennox-Gastaut Syndrome
Completed · Phase 2
Conditions studied: Epilepsy, Epilepsy, Generalized, Seizures
In brief
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.
Key facts
- Study ID
- NCT00162981
- Run by
- Lundbeck LLC
- People needed
- 68
- Starts
- 2005-10-01
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2012-02-09
Who can join
Age: 2 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- Childrens Hospital Los Angeles — Los Angeles, California, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Pediatric Epilepsy & Neurology Specialists — Tampa, Florida, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Childrens Hospital Boston — Boston, Massachusetts, United States
- Minnesota Epilepsy Group, P.A. — Saint Paul, Minnesota, United States
- Children's Hospital — Columbus, Ohio, United States
- University of Tennessee Health Science Center — Memphis, Tennessee, United States
- Dallas Pediatric Neurology Associates — Dallas, Texas, United States
- Texas Child Neurology, LLP — Plano, Texas, United States
- Monarch Medical Research — Norfolk, Virginia, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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