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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2025

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At a glance

  • Drugs Pridopidine (Primary)
  • Indications Huntington's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms PROOF-HD
  • Sponsors Prilenia Therapeutics

Most Recent Events

  • 25 Jul 2025 According to a Prilenia Therapeutics media release, the company announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorization for pridopidine's marketing authorization application for Huntington's disease (HD).
  • 28 Apr 2025 According to a Prilenia Therapeutics media release, the company expect an opinion from the Commission for Medicinal Human Products (CHMP) in the second half of 2025.
  • 05 Nov 2024 According to a Prilenia Therapeutics media release, data from this trial will be presented at the upcoming 31st annual meeting of the Huntington Study Group to be held in Cincinnati, Ohio, November 7-9, 2024.

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