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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: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 30 Jan 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

    • 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, company expects readouts from this study in 2025.
    • 16 Aug 2024 Status changed from recruiting to active, no longer recruiting.

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