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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Excessive Sleepiness, Shift-work Disorder

In brief

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).

Key facts

Study ID

NCT06568367

Run by

Axsome Therapeutics, Inc.

People needed

520

Starts

2024-08-01

Expected to finish

2026-12-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Site — Toronto, Ontario, Canada (enrolling)
• Clinical Research Site — Cullman, Alabama, United States (enrolling)
• Clinical Research Site — Chandler, Arizona, United States (enrolling)
• Clinical Research Site — Ottawa, Ontario, Canada (enrolling)
• Clinical Research Site — Toronto, Ontario, Canada (enrolling)
• Clinical Research Site — Auburn, Alabama, United States (enrolling)
• Clinical Research Site — Little Rock, Arkansas, United States (enrolling)
• Clinical Research Site — Anaheim, California, United States (enrolling)
• Clinical Research Site — Cerritos, California, United States (enrolling)
• Clinical Research Site — Huntington Beach, California, United States (enrolling)
• Clinical Research Site — Long Beach, California, United States (enrolling)
• Clinical Research Site — Santa Ana, California, United States (enrolling)
• Clinical Research Site — Colorado Springs, Colorado, United States (enrolling)
• Clinical Research Site — Brandon, Florida, United States (enrolling)
• Clinical Research Site — Hialeah, Florida, United States (enrolling)
• Clinical Research Site — Miami, Florida, United States (enrolling)
• Clinical Research Site — Miami, Florida, United States (enrolling)
• Clinical Research Site — Miami Lakes, Florida, United States (enrolling)
• Clinical Research Site — Atlanta, Georgia, United States (enrolling)
• Clinical Research Site — Stockbridge, Georgia, United States (enrolling)
• Clinical Research Site — Chicago, Illinois, United States (enrolling)
• Clinical Research Site — Kenner, Louisiana, United States (enrolling)
• Clinical Research Site — Towson, Maryland, United States (enrolling)
• Clinical Research Site — Boston, Massachusetts, United States (enrolling)
• Clinical Research Site — Lansing, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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