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A replicate second Phase 3 placebo-controlled study assessing Amantadine for multiple sclerosis

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A replicate second Phase 3 placebo-controlled study assessing Amantadine for multiple sclerosis

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2020

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At a glance

  • Drugs Amantadine (Primary)
  • Indications Multiple sclerosis
  • Focus Therapeutic Use

    • Most Recent Events

    • 17 Jun 2020 According to an Adamas Pharmaceuticals media release, further engagement with the U.S. Food and Drug Administration (FDA) to fully understand a potential path to submission confirmed the need for an additional pivotal Phase 3 confirmatory study. Based on these findings, Adamas reconfirms it will not initiate further Phase 3 development in MSW.
    • 17 Jun 2020 According to an Adamas Pharmaceuticals media release, the company has carried out a comprehensive analysis of topline results from the INROADS trial and informed a revised target product profile reflecting the scale of clinical benefit observed in the study. Additional patient, physician, and payer research based on the revised profile projected a limited commercial opportunity.
    • 17 Jun 2020 Status changed from planning to withdrawn prior to enrolment, according to an Adamas Pharmaceuticals media release.

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