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NCT Number: NCT06568367

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

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).

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Key information

Conditions

Excessive Sleepiness Chronobiology Disorders Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Shift-work Disorder Sleep Disorders, Circadian Rhythm Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 of any study procedures.
  • Male or female, aged 18 to 65 inclusive.

Exclusion criteria

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Treatment and study plan

Solriamfetol 150 MG

Drug

Solriamfetol tablets, taken once daily

Solriamfetol 300 mg

Drug

Solriamfetol tablets, taken once daily

Placebo

Drug

Placebo tablets, taken once daily

Primary outcomes

  1. Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).

    Time frame: 12 weeks

  2. Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift.

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

212-332-5061

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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