At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
Ganaxolonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Open-label 12-Week Trial of Adjunctive Ganaxolone Treatment (Part A) in Tuberous Sclerosis Complex-related Epilepsy Followed by Long-term Treatment (Part B)
In Brief
A Phase 2 clinical trial evaluating Ganaxolone for Tuberous Sclerosis. Completed, enrolled 23 participants across 7 sites.
Detailed Summary
To assess preliminary safety and efficacy of ganaxolone as adjunctive therapy for the treatment of primary seizure types in patients with genetically- or clinically-confirmed TSC-related epilepsy through the end of the 12 week treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberous Sclerosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 2020
Enrollment StartApr 2020
Primary CompletionJun 2021
Study CompletionAug 2022
TodayJul 2026
First PostedFeb 26, 2020
Enrollment StartApr 8, 2020
Primary CompletionJun 25, 2021
Study CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.4 years ago
Interventions
Ganaxolonedrug
titration followed by maintenance and extension period