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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

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

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
  • 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.
    • 03 Dec 2018 Primary endpoint (Freedom from the most bothersome symptom (MBS) of rimegepant compared with placebo will be measured using the number of evaluable subjects that report the absence of their MBS at 2 hours post-dose) has been met, according to a Biohaven Pharmaceutical media release.
    • 03 Dec 2018 Primary endpoint (Pain freedom of rimegepant compared with placebo in the acute treatment of migraine will be measured using the number of evaluable subjects that report no pain at 2 hours post-dose) has been met, according to a Biohaven Pharmaceutical media release.
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