NCT06568367

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Excessive Sleepiness
• Shift-work Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-08-23
• Last updated: 2025-11-25

Locations

40 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study