Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder
Axsome Therapeutics, Inc.
520 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria3
- 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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Interventions
Solriamfetol tablets, taken once daily
Solriamfetol tablets, taken once daily
Placebo tablets, taken once daily
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT06568367