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Recruiting
NCT06568367
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Conditions: Excessive Sleepiness, Shift-work Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 520
Sponsor: Axsome Therapeutics, Inc.
Location: Clinical Research Site Auburn Alabama
Summary
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
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.
Source: ClinicalTrials.gov (NCT06568367). StuddyBuddy aggregates publicly available trial information.
