Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Ovation Pharmaceuticals |
---|---|
Information provided by: | Ovation Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00162981 |
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 |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | September 2005 |
Ages Eligible for Study: | 2 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
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 |
Study Director: | Katherine A Tracy, M.D. | Ovation Pharmaceuticals |
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 |
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 |
Therapeutic Uses Nervous System Diseases Central Nervous System Agents Pharmacologic Actions Anticonvulsants |