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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
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).
Eligible subjects must meet the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD). Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol titrated to either 150 mg, 300 mg, or placebo once per night shift for 12 weeks.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Clinical Research Site
Cullman, Alabama, United States
Clinical Research Site
Chandler, Arizona, United States
Clinical Research Site
Tucson, Arizona, United States
Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Cerritos, California, United States
Clinical Research Site
Chula Vista, California, United States
Clinical Research Site
Huntington Beach, California, United States
Clinical Research Site
Long Beach, California, United States
Clinical Research Site
Santa Ana, California, United States
Clinical Research Site
Colorado Springs, Colorado, United States
Start Date
August 1, 2024
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
November 25, 2025
520
ESTIMATED participants
Solriamfetol 150 mg
DRUG
Solriamfetol 300 mg
DRUG
Placebo
DRUG
Lead Sponsor
Axsome Therapeutics, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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