Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAxsome Therapeutics, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Solriamfetol 150 mg
- Solriamfetol 300 mg
- Placebo
Treatment groups
520 Participants
are divided into 3 treatment groupsLocations
40Canada
Clinical Research SiteL3R 1A3, MarkhamOntario, Canada
Clinical Research SiteM5S 3A3, TorontoOntario, Canada
United States
Alabama
Clinical Research Site35055, Cullman United States
Arizona
Clinical Research Site85224, Chandler United States
Sponsors and collaborators
Axsome Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov