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.
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.
Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers
Completed
University Hospital Inselspital, Berne
Phase 3
2009-12-01
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.
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