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

Tuberous Sclerosis Complex Clinical Trial

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)

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05323734
Study type Interventional
Source Marinus Pharmaceuticals
Contact
Status Active, not recruiting
Phase Phase 3
Start date April 1, 2022
Completion date October 31, 2024
View Details
See also
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