Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Excessive Sleepiness, Shift-work Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
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 solriamfetol titrated to either 150 mg, 300 mg, or placebo once per night shift for 12 weeks.
Interventions
- Drug Solriamfetol 150 mg
Solriamfetol tablets, taken once daily - Drug Solriamfetol 300 mg
Solriamfetol tablets, taken once daily - Drug Placebo
Placebo tablets, taken once daily
Primary outcome measures
- Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT). [Time frame: 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. [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 44 centers
- Clinical Research Site — Auburn
- Clinical Research Site — Cullman
- Clinical Research Site — Chandler
- Clinical Research Site — Tucson
- Clinical Research Site — Little Rock
- Clinical Research Site — Anaheim
- Clinical Research Site — Cerritos
- Clinical Research Site — Chula Vista
- … and 36 more centers
Canada · 5 centers
- Clinical Research Site — Calgary
- Clinical Research Site — Markham
- Clinical Research Site — Ottawa
- Clinical Research Site — Toronto
- Clinical Research Site — Toronto
Identifiers
NCT: NCT06568367 · SOL-SWD-301