Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
← catalyst calendarNCT06568367 · readout ≤ 134 d
Sponsored by Axsome Therapeutics, Inc. (industry) · AXSM — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
520estimated
Sites
49
Countries
Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-01 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Excessive Sleepiness
- Shift-work Disorder
Interventions
- Drug: Solriamfetol 150 mg
- Drug: Solriamfetol 300 mg
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFChange from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
measured 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.
measured 12 weeks
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