clinical trial · NCT05323734
Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy
Tuberous Sclerosis ComplexGanaxolonePlacebo
brief 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).
started
Apr 1, 2022
primary completion
Sep 9, 2024
completion
Oct 14, 2024
last updated
Jul 11, 2025
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol