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MOMENTUM: A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

Trial Profile

MOMENTUM: A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2023

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At a glance

  • Drugs Meloxicam/rizatriptan (Primary) ; Meloxicam; Rizatriptan
  • Indications Migraine; Migraine with aura; Migraine without aura
  • Focus Registrational; Therapeutic Use
  • Acronyms MOMENTUM
  • Sponsors Axsome Therapeutics
  • Most Recent Events

    • 07 Aug 2023 According to an Axsome Therapeutics media release, Company now anticipates resubmission of the NDA in the first half of 2024.
    • 27 Apr 2023 Results of pooled analysis from two studies(MOMENTUM: N=1594 and INTERCEPT : N=352) assessing efficacy of AXS-07 compared to placebo in patients with risk factors for inadequate treatment response to acute migraine medication presented at the 75th Annual Meeting of the American Academy of Neurology 2023
    • 27 Apr 2023 Results presented at the 75th Annual Meeting of the American Academy of Neurology 2023
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