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BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine

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Trial Profile

BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Feb 2023

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At a glance

  • Drugs Rimegepant (Primary)
  • Indications Migraine
  • Focus Registrational; Therapeutic Use
  • Sponsors Biohaven Pharmaceuticals; Pfizer

    • Most Recent Events

    • 10 Dec 2022 Results of pooled Subgroup Analyses From 3 Phase 3 studies(n=3507: NCT03235479, NCT03237845 and NCT03461757) assessing the the efficacy of rimegepant for the Acute Treatment of Migraine in patients with with 1 or 2 triptans and those without a history of insufficient response, including triptan-naive and current triptan users,presented at the 16th European headache federation COngress
    • 12 Jun 2022 Results of a post hoc analysis assessed the pain severity trajectories over 48- hours in subjects treating a single moderate or severe migraine attack with rimegepant 75 mg oral disintegrating tablet (ODT) or placebo presented at the 64th Annual Scientific Meeting of the American Headache Society
    • 09 Jun 2022 According to a Biohaven Pharmaceuticals Media Release, data from this trial will be presented at the 64th annual scientific meeting of the American Headache Society (AHS) being held from June 9-12 in Denver, CO; Abstracts will also be published in the June edition of Headache journal or shared as a supplement along with the main edition.
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