At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 129 enrolled
Drug / intervention
Ganaxolone +1 moredrug
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 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC)
In Brief
A Phase 3 clinical trial evaluating Ganaxolone and Placebo for Tuberous Sclerosis Complex. Completed, enrolled 129 participants across 63 sites in 10 countries.
Detailed Summary
This is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase consisting of a 4-week titration period (Day 1 to Day 28) and a 12-week maintenance period (Day 29 to Week 16).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberous Sclerosis Complex
CountriesAustralia, Canada, China, France, Germany, Israel, Italy, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
Enrollment StartApr 2022
First PostedApr 2022
Primary CompletionSep 2024
Study CompletionOct 2024
TodayJul 2026
First PostedApr 12, 2022
Enrollment StartApr 1, 2022
Primary CompletionSep 9, 2024
Study CompletionOct 14, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.2 years ago
Interventions
Ganaxolonedrug
GNX will be administered
Placebodrug
Placebo will be administered