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A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder

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Trial Profile

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2025

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At a glance

  • Drugs Solriamfetol (Primary)
  • Indications Circadian rhythm sleep disorders; Hypersomnia
  • Focus Therapeutic Use
  • Acronyms SUSTAIN
  • Sponsors Axsome Therapeutics

    • Most Recent Events

    • 18 Feb 2025 According to an Axsome Therapeutics media release, Company anticipates topline results from the SUSTAIN Phase 3 trial in 2026.
    • 23 Aug 2024 Status changed from planning to recruiting.
    • 06 May 2024 According to an Axsome Therapeutics media release, company is on track initiate a Phase 3 trial of solriamfetol for the treatment of excessive sleepiness (ES) associated with SWD in the second quarter of 2024.

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