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

Description

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).

Conditions

Excessive Sleepiness, Shift-work Disorder

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Excessive Sleepiness
Intervention / Treatment

-

Contacts and Locations

Chula Vista

Clinical Research Site, Chula Vista, California, United States, 91910

Long Beach

Clinical Research Site, Long Beach, California, United States, 90805

Atlanta

Clinical Research Site, Atlanta, Georgia, United States, 30238

Stockbridge

Clinical Research Site, Stockbridge, Georgia, United States, 30281

Huntersville

Clinical Research Site, Huntersville, North Carolina, United States, 28078

Cincinnati

Clinical Research Site, Cincinnati, Ohio, United States, 45212

Cincinnati

Clinical Research Site, Cincinnati, Ohio, United States, 45245

Wyomissing

Clinical Research Site, Wyomissing, Pennsylvania, United States, 19610

Columbia

Clinical Research Site, Columbia, South Carolina, United States, 29201

San Antonio

Clinical Research Site, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Axsome Therapeutics, Inc.,

Study Record Dates

2026-12