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Recruiting Phase 3 NCT06568367

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

Trial Parameters

Condition Excessive Sleepiness
Sponsor Axsome Therapeutics, Inc.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 520
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-08-01
Completion 2026-12
Interventions
Solriamfetol 150 mgSolriamfetol 300 mgPlacebo

Brief 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.

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