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

NCT06568367

RecruitingPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: Excessive Sleepiness, Shift-work Disorder

Interventions: Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo

Countries: United States, Canada

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (49)
  • Auburn, Alabama, United States
  • Cullman, Alabama, United States
  • Chandler, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Anaheim, California, United States
  • Cerritos, California, United States
  • Chula Vista, California, United States
  • Huntington Beach, California, United States
  • Long Beach, California, United States
  • Santa Ana, California, United States
  • Colorado Springs, Colorado, United States
  • Brandon, Florida, United States
  • Hialeah, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Atlanta, Georgia, United States
  • Stockbridge, Georgia, United States
  • Chicago, Illinois, United States
  • Kenner, Louisiana, United States
  • Towson, Maryland, United States
  • Boston, Massachusetts, United States
  • Lansing, Michigan, United States
  • Novi, Michigan, United States
  • Southfield, Michigan, United States
  • Chesterfield, Missouri, United States
  • St Louis, Missouri, United States
  • Henderson, Nevada, United States
  • + 19 more on CT.gov