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Phase II/III: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine

Trial Profile

Phase II/III: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 27 Sep 2023

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At a glance

  • Drugs Zavegepant (Primary)
  • Indications Migraine; Migraine with aura; Migraine without aura
  • Focus Registrational; Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 27 Apr 2023 Pooled data (N=2061) from NCT03872453, NCT04571060 presented at the 75th Annual Meeting of the American Academy of Neurology 2023.
    • 27 Apr 2023 Results of post-hoc subgroup pooled analysis (N=2061; zavegepant n=1014, placebo n=1047) from NCT03872453 and NCT04571060 assessing the influence of attack frequency on the efficacy of zavegepant nasal spray in the acute treatment of migraine, presented at the 75th Annual Meeting of the American Academy of Neurology 2023.
    • 10 Mar 2023 According to a Pfizer Inc. media release, based on two pivotal randomized, double-blind, placebo-controlled studies, U.S. Food and Drug Administration (FDA) has approved ZAVZPRET(zavegepant), nasal spray for the acute treatment of migraine with or without aura in adults.

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