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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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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: 20 Aug 2024

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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

    • 16 Aug 2024 Status changed from recruiting to active, no longer recruiting.
    • 13 Aug 2024 According to Noema Pharma media release, the company is looking forward to reporting top-line data in the first quarter of next year.
    • 05 Mar 2024 Planned End Date changed from 31 Aug 2025 to 31 Jan 2026.

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