Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT06568367

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

Led by Axsome Therapeutics, Inc. · Updated on 2025-11-25

520

Participants Needed

40

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 40 locations

1

Clinical Research Site

Cullman, Alabama, United States, 35055

Actively Recruiting

2

Clinical Research Site

Chandler, Arizona, United States, 85224

Actively Recruiting

3

Clinical Research Site

Tucson, Arizona, United States, 85704

Actively Recruiting

4

Clinical Research Site

Little Rock, Arkansas, United States, 72211

Actively Recruiting

5

Clinical Research Site

Cerritos, California, United States, 90703

Actively Recruiting

6

Clinical Research Site

Chula Vista, California, United States, 91910

Actively Recruiting

7

Clinical Research Site

Huntington Beach, California, United States, 92647

Actively Recruiting

8

Clinical Research Site

Long Beach, California, United States, 90805

Actively Recruiting

9

Clinical Research Site

Santa Ana, California, United States, 92705

Actively Recruiting

10

Clinical Research Site

Colorado Springs, Colorado, United States, 80918

Actively Recruiting

11

Clinical Research Site

Brandon, Florida, United States, 33511

Actively Recruiting

12

Clinical Research Site

Hialeah, Florida, United States, 33016

Actively Recruiting

13

Clinical Research Site

Miami, Florida, United States, 33135

Actively Recruiting

14

Clinical Research Site

Miami, Florida, United States, 33144

Actively Recruiting

15

Clinical Research Site

Miami, Florida, United States, 33176

Actively Recruiting

16

Clinical Research Site

Miami Lakes, Florida, United States, 33016

Actively Recruiting

17

Clinical Research Site

Atlanta, Georgia, United States, 30238

Actively Recruiting

18

Clinical Research Site

Stockbridge, Georgia, United States, 30281

Actively Recruiting

19

Clinical Research Site

Towson, Maryland, United States, 21286

Actively Recruiting

20

Clinical Research Site

Boston, Massachusetts, United States, 02115

Actively Recruiting

21

Clinical Research Site

Lansing, Michigan, United States, 48911

Actively Recruiting

22

Clinical Research Site

Novi, Michigan, United States, 48377

Actively Recruiting

23

Clinical Research Site

Southfield, Michigan, United States, 48075

Actively Recruiting

24

Clinical Research Site

Chesterfield, Missouri, United States, 63017

Actively Recruiting

25

Clinical Research Site

St Louis, Missouri, United States, 63123

Actively Recruiting

26

Clinical Research Site

Henderson, Nevada, United States, 89052

Actively Recruiting

27

Clinical Research Site

Middletown, New Jersey, United States, 07748

Actively Recruiting

28

Clinical Research Site

Denver, North Carolina, United States, 28037

Actively Recruiting

29

Clinical Research Site

Fayetteville, North Carolina, United States, 28304

Actively Recruiting

30

Clinical Research Site

Huntersville, North Carolina, United States, 28078

Actively Recruiting

31

Clinical Research Site

Cincinnati, Ohio, United States, 45212

Actively Recruiting

32

Clinical Research Site

Cincinnati, Ohio, United States, 45245

Actively Recruiting

33

Clinical Research Site

Wyomissing, Pennsylvania, United States, 19610

Actively Recruiting

34

Clinical Research Site

Charleston, South Carolina, United States, 29425

Actively Recruiting

35

Clinical Research Site

Columbia, South Carolina, United States, 29201

Actively Recruiting

36

Clinical Research Site

Houston, Texas, United States, 77070

Actively Recruiting

37

Clinical Research Site

San Antonio, Texas, United States, 78229

Actively Recruiting

38

Clinical Research Site

Sugar Land, Texas, United States, 77478

Actively Recruiting

39

Clinical Research Site

Markham, Ontario, Canada, L3R 1A3

Actively Recruiting

40

Clinical Research Site

Toronto, Ontario, Canada, M5S 3A3

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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