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Displaying 3 studies
The purose of this study is to compare the safety and effectiveness of two different strengths of Rapamycin cream, topical and placebo over 26 weeks in the treatment of facial angiofibroma (FA) associated with Tuberous Sclerosis Complex (TSC).
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.
The purpose of this trial is to assess the safety and effectiveness of Ganaxolone (GNX) compared to placebo as adjunctive therapy for seizures associated with Tuberous Sclerosis Complex (TSC) in children and adults as assessed by the change from baselinea in the frequency of countable major motor and focal seizures (primary endpoint seizuresb) during the double-blind phase.