Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Last updated: January 21, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Sleep Disorders

Treatment

Placebo

Solriamfetol 300 mg

Solriamfetol 150 mg

Clinical Study ID

NCT06568367
SOL-SWD-301
  • Ages 18-65
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets International Classification of Sleep Disorders, Third Edition (ICSD-3)criteria for Shift Work Disorder (SWD)

  • Provides written informed consent to participate in the study before the conduct ofany study procedures.

  • Male or female, aged 18 to 65 inclusive.

Exclusion

Exclusion Criteria:

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study orprescription.

  • Unable to comply with study procedures.

  • Medically inappropriate for study participation in the opinion of the investigator.

Study Design

Total Participants: 520
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 01, 2024
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Clinical Research Site

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Clinical Research Site

    Cerritos, California 90703
    United States

    Active - Recruiting

  • Clinical Research Site

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • Clinical Research Site

    Long Beach, California 90805
    United States

    Active - Recruiting

  • Clinical Research Site

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Clinical Research Site

    Colorado Springs, Colorado 80918
    United States

    Active - Recruiting

  • Clinical Research Site

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Clinical Research Site

    Atlanta, Georgia 30238
    United States

    Active - Recruiting

  • Clinical Research Site

    Stockbridge, Georgia 30281
    United States

    Active - Recruiting

  • Clinical Research Site

    Lathrup Village, Michigan 48076
    United States

    Active - Recruiting

  • Clinical Research Site

    Novi, Michigan 48377
    United States

    Active - Recruiting

  • Clinical Research Site

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • Clinical Research Site

    Saint Louis, Missouri 63123
    United States

    Active - Recruiting

  • Clinical Research Site

    Denver, North Carolina 28037
    United States

    Active - Recruiting

  • Clinical Research Site

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Clinical Research Site

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • Clinical Research Site

    Wyomissing, Pennsylvania 19610
    United States

    Active - Recruiting

  • Clinical Research Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Clinical Research Site

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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