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BHV3000-302 : Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

Trial Profile

BHV3000-302 : Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Dec 2018

At a glance

  • Drugs Rimegepant (Primary)
  • Indications Migraine
  • Focus Registrational; Therapeutic Use
  • Sponsors Biohaven Pharmaceutical; Biohaven Pharmaceutical Holding Company
  • Most Recent Events

    • 03 Dec 2018 According to a Biohaven Pharmaceutical media release, the co-primary endpoints achieved in the three pivotal phase 3 trials (BHV3000-301, BHV3000-302 and BHV3000-303) are consistent with regulatory guidance from the U.S. Food and Drug Administration (FDA) and provide the basis for a planned submission of a new drug application (NDA) to the FDA in the first half of 2019.
    • 06 Sep 2018 According to a Biohaven Pharmaceutical Holding Company media release, data from two pivotal trials (Study 301 and Study 302) will be presented at the 17th Biennial Migraine Trust International Symposium (MTIS).
    • 28 Jun 2018 Results published in the Biohaven Pharmaceutical Holding Company Media Release
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