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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Solriamfetol 150mg 		Up to 12 weeks
  • Drug: Solriamfetol 150 mg
    Solriamfetol tablets, taken once daily
Experimental
Solriamfetol 300mg 		Up to 12 weeks
  • Drug: Solriamfetol 300 mg
    Solriamfetol tablets, taken once daily
Placebo Comparator
Placebo 		Up to 12 weeks
  • Drug: Placebo
    Placebo tablets, taken once daily

Recruiting Locations

Clinical Research Site
Auburn, Alabama 36832

Clinical Research Site
Cullman, Alabama 35055

Clinical Research Site
Chandler, Arizona 85224

Clinical Research Site
Little Rock, Arkansas 72211

Clinical Research Site
Anaheim, California 92801

Clinical Research Site
Cerritos, California 90703

Clinical Research Site
Huntington Beach, California 92647

Clinical Research Site
Long Beach, California 90805

Clinical Research Site
Santa Ana, California 92705

Clinical Research Site
Colorado Springs, Colorado 80918

Clinical Research Site
Brandon, Florida 33511

Clinical Research Site
Hialeah, Florida 33016

Clinical Research Site
Miami, Florida 33135

Clinical Research Site
Miami, Florida 33176

Clinical Research Site
Miami Lakes, Florida 33016

Clinical Research Site
Atlanta, Georgia 30238

Clinical Research Site
Stockbridge, Georgia 30281

Clinical Research Site
Chicago, Illinois 60634

Clinical Research Site
Kenner, Louisiana 70065

Clinical Research Site
Towson, Maryland 21286

Clinical Research Site
Boston, Massachusetts 02115

Clinical Research Site
Lansing, Michigan 48911

Clinical Research Site
Novi, Michigan 48377

Clinical Research Site
Southfield, Michigan 48075

Clinical Research Site
Chesterfield, Missouri 63017

Clinical Research Site
St Louis, Missouri 63123

Clinical Research Site
Henderson, Nevada 89052

Clinical Research Site
Middletown, New Jersey 07748

Clinical Research Site
Denver, North Carolina 28037

Clinical Research Site
Fayetteville, North Carolina 28304

Clinical Research Site
Huntersville, North Carolina 28078

Clinical Research Site
Cincinnati, Ohio 45212

Clinical Research Site
Cincinnati, Ohio 45245

Clinical Research Site
Wyomissing, Pennsylvania 19610

Clinical Research Site
Charleston, South Carolina 29425

Clinical Research Site
Columbia, South Carolina 29201

Clinical Research Site
Houston, Texas 77058

Clinical Research Site
Houston, Texas 77070

Clinical Research Site
San Antonio, Texas 78229

Clinical Research Site
Sugar Land, Texas 77478

Clinical Research Site
Spokane, Washington 99204

More Details

Status
Recruiting
Sponsor
Axsome Therapeutics, Inc.

Study Contact

Study Director
212-332-5061
sol-swd-301@axsome.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.