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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: Recruiting
Phase of Trial: Phase II

Latest Information Update: 14 May 2024

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At a glance

  • Drugs Basimglurant (Primary)
  • Indications Seizures; Tuberous sclerosis
  • Focus Therapeutic Use
  • Sponsors Noema Pharma
  • Most Recent Events

    • 05 Mar 2024 Planned End Date changed from 31 Aug 2025 to 31 Jan 2026.
    • 05 Mar 2024 Planned primary completion date changed from 31 Mar 2024 to 30 Nov 2024.
    • 06 Apr 2023 Planned primary completion date changed from 30 Nov 2023 to 31 Mar 2024.
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