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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

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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: 08 Aug 2024

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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

    • 05 Aug 2024 According to an Axsome media release, the company has resubmitted its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.
    • 06 May 2024 According to an Axsome Therapeutics media release, NDA resubmission for AXS-07 in migraine expected in for 2Q 2024. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review.
    • 15 Apr 2024 According to an Axsome Therapeutics media release, the company will present data from MOMENTUM and INTERCEPT Phase 3 trials at the American Academy of Neurology (AAN) 2024 annual meeting, being held April 13-18, 2024, in Denver, Colorado.

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