Clobazam in Patients With Lennox-Gastaut Syndrome

Completed · Phase 3 · Has a placebo group

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 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.

Key facts

Study ID

NCT00518713

Run by

Lundbeck LLC

People needed

238

Starts

2007-08-01

Expected to finish

2010-04-01

Last updated by the study team

2012-02-09

Who can join

Age: 2 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have been <11 years of age at the onset of LGS.
• Patient must have LGS.
• Patient must be on at least 1 AED.
• Parent or caregiver must be able to keep an accurate seizure diary.

You may not qualify if…

• Etiology of patient's seizures is a progressive neurologic disease. Patients with tuberous sclerosis will not be excluded from study participation, unless there is a progressive tumor.
• Patient has had an episode of status epilepticus within 12 weeks of baseline.
• Patient has had an anoxic episode requiring resuscitation within 6 months of screening.
• Patient has a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines.
• Patient is taking more than 3 concurrent AEDs.
• Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers from frequent stooling.
• If the patient has a Vagal Nerve Stimulator (VNS), the settings have not been stable for at least 30 days prior to screening.
• Patient has taken corticotropins in the 6 months prior to screening.
• Patient is currently taking long-term systemic steroids (excluding inhaled mediation for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for idiopathic nephrotic syndrome or asthma.
• If the patient is taking felbamate, has been taking it for less than 1 year prior to screening.
• Other protocol-defined inclusion and exclusion criteria may apply.

Where it is running

• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Childrens Hospital Los Angeles — Los Angeles, California, United States
• The Children's Hospital — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Pediatric Neurology and Epilepsy Center — Loxahatchee Groves, Florida, United States
• Child Neurology Center of NW FL — Pensacola, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Pediatric Epilepsy & Neurology Specialists — Tampa, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Pediatric Neurology of Idaho Children's Specialty Center — Boise, Idaho, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• University of Kentucky, Kentucky Clinic, Department of Neurology — Lexington, Kentucky, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Minnesota Epilepsy Group — Saint Paul, Minnesota, United States
• The Comprehensive Epilepsy Care Center for Children and Adults — Chesterfield, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• St. Joseph's Regional Medical Center — Paterson, New Jersey, United States
• Clinical Research Center of New Jersey (CRCNJ) — Voorhees Township, New Jersey, United States
• University of Alabama at Birmingham — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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