Status:
RECRUITING
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Lead Sponsor:
Axsome Therapeutics, Inc.
Conditions:
Excessive Sleepiness
Shift-work Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 tria...
Detailed Description
Eligible subjects must meet the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD). Subjects will be randomized in a 1:1:1 ratio to receive ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT06568367
Start Date
August 1 2024
End Date
December 1 2026
Last Update
November 25 2025
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Site
Cullman, Alabama, United States, 35055
2
Clinical Research Site
Chandler, Arizona, United States, 85224
3
Clinical Research Site
Tucson, Arizona, United States, 85704
4
Clinical Research Site
Little Rock, Arkansas, United States, 72211