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Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease): A Multinational, Multicenter, Open-label, Rater-blinded Phase II Study

Trial Profile

Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease): A Multinational, Multicenter, Open-label, Rater-blinded Phase II Study

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs L-Acetylleucine (Primary)
  • Indications GM2 gangliosidoses; Sandhoff disease; Tay-Sachs disease
  • Focus Therapeutic Use
  • Acronyms IB1001-202
  • Sponsors IntraBio
  • Most Recent Events

    • 28 Feb 2023 Status changed from active, no longer recruiting to completed.
    • 01 Dec 2022 Results assessing the efficacy and safety of N-Acetyl-L-Leucine in patients with GM2 gangliosidoses, published in the Neurology.
    • 02 Aug 2022 Planned End Date changed from 1 Dec 2022 to 1 Dec 2023.
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