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Clobazam in Subjects With Lennox-Gastaut Syndrome
This study is ongoing, but not recruiting participants.
Sponsored by: Ovation Pharmaceuticals
Information provided by: Ovation Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00162981
  Purpose

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. 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.


Condition Intervention Phase
Epilepsy
Epilepsy, Generalized
Seizures
Drug: Clobazam
Phase II

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Clobazam
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment
Official Title: Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome

Further study details as provided by Ovation Pharmaceuticals:

Primary Outcome Measures:
  • Percent reduction in number of drop seizures from the baseline period compared to the maintenance period.

Secondary Outcome Measures:
  • Percent of subjects considered treatment responders defined as those with a >/= 25%, >/= 50%, >/= 75% reduction in drop seizures from the baseline period compared to the maintenance period.
  • Parent/Caregiver global evaluations of seizure activity and quality of life.

Estimated Enrollment: 60
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   2 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key 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 antiepileptic drug (AED).
  • Parent or caregiver must be able to keep an accurate seizure diary.

Key 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 a history of an allergic reaction or significant sensitivity to benzodiazepines.
  • Subject is taking more than 3 concurrent AEDs. Note: 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162981

Locations
United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, United States, 33609
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Minnesota
Minnesota Epilepsy Group, P.A.
St. Paul, Minnesota, United States, 55102
United States, Ohio
Children's Hospital
Columbus, Ohio, United States, 43205
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38105
United States, Texas
Texas Child Neurology, LLP
Plano, Texas, United States, 75075
Dallas Pediatric Neurology Associates
Dallas, Texas, United States, 75230
United States, Virginia
Monarch Medical Research
Norfolk, Virginia, United States, 23510
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Ovation Pharmaceuticals
Investigators
Study Director: Katherine A Tracy, M.D. Ovation Pharmaceuticals
  More Information

Study ID Numbers: OV-1002
Study First Received: September 9, 2005
Last Updated: May 24, 2006
ClinicalTrials.gov Identifier: NCT00162981  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Paralysis
Signs and Symptoms
Hemiplegia
Epilepsy
Epileptic encephalopathy, Lennox-Gastaut type
Seizures
Cutis verticis gyrata
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Epilepsy, Generalized
Clobazam

Additional relevant MeSH terms:
Therapeutic Uses
Nervous System Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009