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A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy

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Trial Profile

A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 Feb 2025

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At a glance

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

Most Recent Events

  • 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.
  • 28 Aug 2020 According to an Axsome Therapeutics media release, data from the study will be presented at the 34th Annual SLEEP Meeting of the Associated Professional Sleep Societies (APSS) 2020. A copy of the presentation will be available shortly after the meeting on Axsome's website at www.axsome.com.
  • 05 Aug 2020 According to an Axsome Therapeutics media release, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in patients with narcolepsy, based on data from this trial.

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