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A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults with Uncontrolled Seizures Associated with Tuberous Sclerosis Complex

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Trial Profile

A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults with Uncontrolled Seizures Associated with Tuberous Sclerosis Complex

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Basimglurant (Primary)
  • Indications Seizures; Tuberous sclerosis
  • Focus Therapeutic Use
  • Acronyms GALENE
  • Sponsors Noema Pharma

Most Recent Events

  • 04 Jun 2025 Status changed from active, no longer recruiting to completed.
  • 28 Jan 2025 Planned primary completion date changed from 30 Nov 2024 to 30 Mar 2025.
  • 11 Dec 2024 According to Noema Pharma media release, the company extends Series B financing round, closing at CHF 130 Million ($147 Million).The financing will support this trial and key data readouts anticipated in 2025.

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