NCT05323734

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tuberous Sclerosis Complex

Interventions

Type	Name	Description
DRUG	Ganaxolone	GNX will be administered
DRUG	Placebo	Placebo will be administered

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-09-09
• Completion: 2024-10-14
• First posted: 2022-04-12
• Last updated: 2025-07-11
• Results posted: 2025-07-11

Locations

63 sites across 10 countries: United States, Australia, Canada, China, France, Germany, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study