drugset / Trial / NCT06568367

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

NCT06568367

Phase 3 Recruiting 520 enrolled Axsome Therapeutics, Inc.
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2024-08-01
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Solriamfetol Small molecule 150 mg
Subject Solriamfetol Small molecule 300 mg