Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy

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).

Timeline

Start

2022-04-01

Primary completion

2024-09-09

Completion

2024-10-14

Outcome

Missed primary endpoint

registry analysis (other test); Ganaxolone vs Matching Placebo; p = 0.0904; Median Difference (Final Values) -14.53 (95% CI -32.04 to 2.48) NCT05323734 ↗

Drugs

Indications