NCT06568367 Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
| NCT ID | NCT06568367 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Axsome Therapeutics, Inc. |
| Condition | Excessive Sleepiness |
| Study Type | INTERVENTIONAL |
| Enrollment | 520 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 520 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06568367 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Excessive Sleepiness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06568367 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 520 participants.
Is NCT06568367 currently recruiting?
Yes, NCT06568367 is actively recruiting participants. Contact the research team at sol-swd-301@axsome.com for enrollment information.
Where is the NCT06568367 trial being conducted?
This trial is being conducted at Auburn, United States, Cullman, United States, Chandler, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT06568367 clinical trial?
NCT06568367 is sponsored by Axsome Therapeutics, Inc.. The trial plans to enroll 520 participants.