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Tracking Information | |||||
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First Received Date † | September 9, 2005 | ||||
Last Updated Date | May 24, 2006 | ||||
Start Date † | September 2005 | ||||
Current Primary Outcome Measures † |
Percent reduction in number of drop seizures from the baseline period compared to the maintenance period. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00162981 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Clobazam in Subjects With Lennox-Gastaut Syndrome | ||||
Official Title † | Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome | ||||
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. 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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment | ||||
Condition † |
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Intervention † | Drug: Clobazam | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 60 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Key Inclusion Criteria:
Key Exclusion Criteria:
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Gender | Both | ||||
Ages | 2 Years to 30 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00162981 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Ovation Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Ovation Pharmaceuticals | ||||
Verification Date | May 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |