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
1 other identifier
interventional
520
2 countries
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2024
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 25, 2025
November 1, 2025
2.3 years
August 21, 2024
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
12 weeks
Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift.
12 weeks
Study Arms (3)
Solriamfetol 150mg
EXPERIMENTALUp to 12 weeks
Solriamfetol 300mg
EXPERIMENTALUp to 12 weeks
Placebo
PLACEBO COMPARATORUp to 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Clinical Research Site
Cullman, Alabama, 35055, United States
Clinical Research Site
Chandler, Arizona, 85224, United States
Clinical Research Site
Tucson, Arizona, 85704, United States
Clinical Research Site
Little Rock, Arkansas, 72211, United States
Clinical Research Site
Cerritos, California, 90703, United States
Clinical Research Site
Chula Vista, California, 91910, United States
Clinical Research Site
Huntington Beach, California, 92647, United States
Clinical Research Site
Long Beach, California, 90805, United States
Clinical Research Site
Santa Ana, California, 92705, United States
Clinical Research Site
Colorado Springs, Colorado, 80918, United States
Clinical Research Site
Brandon, Florida, 33511, United States
Clinical Research Site
Hialeah, Florida, 33016, United States
Clinical Research Site
Miami, Florida, 33135, United States
Clinical Research Site
Miami, Florida, 33144, United States
Clinical Research Site
Miami, Florida, 33176, United States
Clinical Research Site
Miami Lakes, Florida, 33016, United States
Clinical Research Site
Atlanta, Georgia, 30238, United States
Clinical Research Site
Stockbridge, Georgia, 30281, United States
Clinical Research Site
Towson, Maryland, 21286, United States
Clinical Research Site
Boston, Massachusetts, 02115, United States
Clinical Research Site
Lansing, Michigan, 48911, United States
Clinical Research Site
Novi, Michigan, 48377, United States
Clinical Research Site
Southfield, Michigan, 48075, United States
Clinical Research Site
Chesterfield, Missouri, 63017, United States
Clinical Research Site
St Louis, Missouri, 63123, United States
Clinical Research Site
Henderson, Nevada, 89052, United States
Clinical Research Site
Middletown, New Jersey, 07748, United States
Clinical Research Site
Denver, North Carolina, 28037, United States
Clinical Research Site
Fayetteville, North Carolina, 28304, United States
Clinical Research Site
Huntersville, North Carolina, 28078, United States
Clinical Research Site
Cincinnati, Ohio, 45212, United States
Clinical Research Site
Cincinnati, Ohio, 45245, United States
Clinical Research Site
Wyomissing, Pennsylvania, 19610, United States
Clinical Research Site
Charleston, South Carolina, 29425, United States
Clinical Research Site
Columbia, South Carolina, 29201, United States
Clinical Research Site
Houston, Texas, 77070, United States
Clinical Research Site
San Antonio, Texas, 78229, United States
Clinical Research Site
Sugar Land, Texas, 77478, United States
Clinical Research Site
Markham, Ontario, L3R 1A3, Canada
Clinical Research Site
Toronto, Ontario, M5S 3A3, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 23, 2024
Study Start
August 1, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share