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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

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: 17 Apr 2024

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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

    • 12 Apr 2024 According to a Prilenia Therapeutics media release, company announced the oral and poster presentation of the latest research from this study to be presented at the American Academy of Neurology (AAN) Annual Congress, in Denver, Colorado, April 13-18.
    • 12 Mar 2024 According to a Prilenia Therapeutics media release, company intends to discuss with the U.S. Food and Drug Administration (FDA) a potential path forward for pridopidine as a possible treatment for those living with HD in the United States. The Company will also consider global regulatory submissions for additional countries and regions following the regulatory review process in Europe.
    • 12 Mar 2024 According to a Prilenia Therapeutics media release, company plans to submit a Marketing Authorization Application (MAA) for pridopidine for the treatment of Huntingtons disease (HD) to the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP). This decision follows positive pre-submission meetings with regulatory authorities in the European Union. Submission is planned for mid-2024.
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