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A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2025

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At a glance

  • Drugs Reboxetine (Primary)
  • Indications Cataplexy; Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms SYMPHONY
  • Sponsors Axsome Therapeutics

    • Most Recent Events

    • 04 Apr 2025 According to Axsome Therapeutics media release, the company announced presentation of this trial data at psychiatry and neurology portfolio at the 2025 American Academy of Neurology (AAN) Annual Meeting, being held April 5-9 in San Diego, California.
    • 18 Feb 2025 According to Axsome Therapeutics media release, the company announced that based on the results from CONCERT, SYMPHONY, and ENCORE studies, the company plans to submit an NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy to the FDA in the second half of 2025.
    • 24 Sep 2024 According to an Axsome Therapeutics media release, company to present topline Results from the Phase 3 SYMPHONY Trial at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society, being held September 24-27, 2024, in Seville, Spain.

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