Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Phase 3

Recruiting

• Conditions: Shift-work Disorder; Excessive Sleepiness
• Interventions: Drug: Solriamfetol 300 mg; Drug: Solriamfetol 150 mg; Drug: Placebo

• Registration Number: NCT06568367
• Lead Sponsor: Axsome Therapeutics, Inc.

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).

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.

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solriamfetol 300mg	Solriamfetol 300 mg	Up to 12 weeks
Solriamfetol 150mg	Solriamfetol 150 mg	Up to 12 weeks
Placebo	Placebo	Up to 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 San Antonio, Texas, United States