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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)

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Trial Profile

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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2024

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At a glance

  • Drugs Ganaxolone (Primary)
  • Indications Absence epilepsy; Generalised seizures; Myoclonic epilepsies; Seizures; Tonic-clonic epilepsy; Tuberous sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms TrustTSC
  • Sponsors Marinus Pharmaceuticals

Most Recent Events

  • 29 Oct 2024 Status changed from active, no longer recruiting to discontinued, according to an Orion media release.
  • 24 Oct 2024 According to a Marinus Pharmaceuticals media release, As a result of the TrustTSC outcome, Marinus is discontinuing further ganaxolone clinical development and is taking additional steps to reduce costs, including a reduction in its workforce.
  • 24 Oct 2024 According to a Marinus Pharmaceuticals media release, Primary endpoint (Double-blind phase: Percent change from Baseline in 28-day seizure frequency during titration and maintenance period) has not been met.

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