Trials / Terminated
TerminatedNCT05604170
Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy
A Phase 3, Open-label Study of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC OLE)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- Marinus Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Year – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, global, open-label extension (OLE) study of adjunctive GNX treatment in children and adults with TSC who previously participated in either Study 1042-TSC-3001 or Study 1042-TSC-2001
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ganaxolone | GNX will be administered. |
Timeline
- Start date
- 2022-05-16
- Primary completion
- 2025-04-02
- Completion
- 2025-04-02
- First posted
- 2022-11-03
- Last updated
- 2025-10-01
- Results posted
- 2025-10-01
Locations
54 sites across 10 countries: United States, Australia, Canada, China, France, Germany, Israel, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05604170. Inclusion in this directory is not an endorsement.