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A Study to Assess the Long-term 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 Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 May 2024

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At a glance

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

    • Most Recent Events

    • 06 May 2024 According to an Axsome Therapeutics media, A Phase 3 open label safety extension trial of AXS-12 is currently ongoing with completion anticipated in the fourth quarter of 2024. Topline results from this trial anticipated in 2H 2024.
    • 17 Jan 2024 Planned End Date changed from 1 Dec 2023 to 1 Dec 2024.
    • 17 Jan 2024 Planned primary completion date changed from 1 Dec 2023 to 1 Dec 2024.

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