Clobazam in Subjects With Lennox-Gastaut Syndrome

NCT ID: NCT00162981

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Clobazam Low Dose

Group Type: EXPERIMENTAL

Clobazam Low Dose

Intervention Type: DRUG

5 to 10 mg/day with doses in the morning and at bedtime; orally

Clobazam High Dose

Group Type: EXPERIMENTAL

Clobazam High Dose

Intervention Type: DRUG

5 to 40 mg/day with doses in the morning and at bedtime; orally

Interventions

Clobazam Low Dose

5 to 10 mg/day with doses in the morning and at bedtime; orally

Intervention Type: DRUG

Clobazam High Dose

5 to 40 mg/day with doses in the morning and at bedtime; orally

Intervention Type: DRUG

Other Intervention Names

Onfi™; Onfi™

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation
• Subject has had an episode of status epilepticus within 12 weeks of baseline
• Subject has had an anoxic episode requiring resuscitation within 1 year of screening
• Subject has had a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines
• Subject is taking more than 3 concurrent AEDs. Note: Vagal Nerve Stimulation (VNS) or ketogenic diet is allowed and each will be counted as one of the three allowed AEDs
• If the subject is on the ketogenic diet, has been for less than 4 weeks prior to screening or suffers from frequent stooling
• If the subject has a VNS, the settings have not been stable for at least 4 weeks prior to screening
• Subject has taken corticotropins in the 6 months prior to screening
• Subject is currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for urinary tract infections or asthma
• If the subject is taking felbamate, has been taking it for less than 1 year prior to screening or previous treatment with felbamate resulted in withdrawal due to liver or bone marrow adverse events

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lundbeck LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

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

Countries

United States

References

Conry JA, Ng YT, Paolicchi JM, Kernitsky L, Mitchell WG, Ritter FJ, Collins SD, Tracy K, Kormany WN, Abdulnabi R, Riley B, Stolle J. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia. 2009 May;50(5):1158-66. doi: 10.1111/j.1528-1167.2008.01935.x. Epub 2008 Dec 15.

Reference Type: BACKGROUND

PMID: 19170737 (View on PubMed)

Other Identifiers

OV1002

Identifier Type: OTHER

Identifier Source: secondary_id

13108A

Identifier Type: -

Identifier Source: org_study_id