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TrustTSC OLE open-label phase 3 ganaxolone add-on therapy in TSC-associated epilepsy
CTR20233334Phase 3Terminated
- Sponsor
- Marinus Pharmaceuticals
- Start
- Oct 2023
- Modality
- Allosteric Modulators → Classical Binding Small Molecules → Small Molecules
- Countries
- 1
01
Overview
Phase 3, open-label, single-arm trial of ganaxolone in epilepsy, sponsored by Marinus Pharmaceuticals. Primary endpoints: Participants with adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or dose reduction, Participants with abnormalities in vital signs, physical, neurological and developmental examinations, and 12-lead ECG results and 1 more. Started Oct 2023; status: terminated.
02
Drugs
ganaxolone
03
Conditions
epilepsy
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