Evaluating Solriamfetol for Excessive Sleepiness in Shift Workers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SUSTAIN trial is a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of solriamfetol in adults experiencing excessive sleepiness due to shift work disorder (SWD). Participants will be randomly assigned to receive either solriamfetol at doses of 150 mg or 300 mg, or a placebo, administered once per night shift over a 12-week period. The study aims to determine how well solriamfetol modulates neurotransmitters associated with wakefulness and alertness in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Research Site
  Auburn, Alabama, United States Recruiting
• Clinical Research Site
  Cullman, Alabama, United States Recruiting
• Clinical Research Site
  Chandler, Arizona, United States Recruiting
• Clinical Research Site
  Little Rock, Arkansas, United States Recruiting
• Clinical Research Site
  Anaheim, California, United States Recruiting
• Clinical Research Site
  Cerritos, California, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: sol-swd-301@axsome.com
• Phone: 212-332-5061

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.