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A Phase 3, Randomized, Double-Blind, Multicenter, Controlled Trial to Assess the Efficacy and Safety of AXS-07 in the Acute Treatment of Migraine

Trial Profile

A Phase 3, Randomized, Double-Blind, Multicenter, Controlled Trial to Assess the Efficacy and Safety of AXS-07 in the Acute Treatment of Migraine

Planning
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2019

At a glance

  • Drugs Meloxicam/rizatriptan (Primary) ; Meloxicam; Rizatriptan
  • Indications Migraine
  • Focus Registrational; Therapeutic Use
  • Acronyms MOMENTUM
  • Sponsors Axsome Therapeutics
  • Most Recent Events

    • 06 Feb 2019 According to an Axsome Therapeutics media release, based on FDA feedback during the SPA process, Axsome believes that only one phase 3 trial may be needed for the approval of AXS-07.This trial is adequately designed to support an NDA filing for marketing approval.
    • 06 Feb 2019 According to an Axsome Therapeutics media release, the company has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design, endpoints, and statistical approach of this trial.The SPA provides agreement that, this trial design adequately addresses objectives that, if met, will support the regulatory submission for approval of AXS-07 for the indication of acute treatment of migraine in adults with or without aura.
    • 27 Dec 2018 According to an Axsome Therapeutics media release, company anticipates initiating this study in the first quarter of 2019, with topline results expected within approximately one year from trial initiation.
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