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CLINICAL TRIALS PROFILE FOR CLOBAZAM

Clinical Trials for Clobazam

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00162981	Clobazam in Subjects With Lennox-Gastaut Syndrome	Completed	Lundbeck LLC	Phase 2	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.
NCT00518713	Clobazam in Patients With Lennox-Gastaut Syndrome	Completed	Lundbeck LLC	Phase 3	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.
NCT01011036	Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers	Completed	University Hospital Inselspital, Berne	Phase 3	The investigators will use an intradermal capsaicin injection in the forearm to induce a state of localized pain. This localized pain will be measured by different means, and analysed locally and distally by so called quantitative sensory testing. The primary endpoint of measure is the difference in pain perception with and without benzodiazepines/GABA-Agonists around the injection point of capsaicin. The secondary endpoints are to measure pain modulation locally and distally by different quantitative tests as electricity, pressure pain thresholds, and ice water tests. The investigators' hypothesis is that clobazam induces higher pain thresholds as placebo and less sedation than the control medication clonazepam.
NCT01160770	Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome	Completed	Lundbeck LLC	Phase 3	The objective of this study is to evaluate the long-term safety and effectiveness of open-label clobazam in the treatment of drop seizures in subjects with LGS.
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