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RecruitingPhase 3

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

Axsome Therapeutics, Inc. · NCT06568367

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
520
US sites recruiting
41
Study start
August 1, 2024
Record last updated
July 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Solriamfetol 150 mg; Solriamfetol 300 mg; Placebo

Conditions: Excessive Sleepiness; Shift-work Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Study Director · 212-332-5061 · sol-swd-301@axsome.com
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Studying Solriamfetol Modulation of TAAR-1, Dopamine, and… (NCT06568367) | Bored Studies