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A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NMD670 Over 21 Days in Ambulatory Adult Patients with Type 1 and Type 2 Charcot-Marie-Tooth Disease

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A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NMD670 Over 21 Days in Ambulatory Adult Patients with Type 1 and Type 2 Charcot-Marie-Tooth Disease

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Mar 2025

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At a glance

  • Drugs Bromophenoxyazole propanoic acid (Primary)
  • Indications Charcot-Marie-Tooth disease
  • Focus Therapeutic Use
  • Acronyms ESTABLISH1; SYNAPSE-CMT

    • Most Recent Events

    • 06 Jan 2025 According to a NMD Pharma media release, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for NMD670, for the treatment of Charcot-Marie-Tooth disease (CMT).
    • 06 Jan 2025 According to a NMD Pharma media release, the company has three ongoing global clinical trials investigating NMD670 including a Phase 2 study in adults living with spinal muscular atrophy (SMA) type 3, a Phase 2b study in gMG patients, and this Phase 2 CMT study, with data readout(s) occurring from 2H/2025 through 1H/2026.
    • 18 Dec 2024 According to a NMD Pharma media release, new data from this study were published in the journal Annals of Clinical and Translational Neurology with collaborators from the Aarhus University Hospital, University of Missouri, The Ohio State University, and Aarhus University.

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