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NCT06568367PHASE3Recruiting

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

Axsome Therapeutics, Inc.

Start Date

8/1/2024

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: 18 years to 65 years

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.

Interventions

DRUG

Solriamfetol 150 mg

DRUG

Solriamfetol 300 mg

DRUG

Placebo

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Conditions

Excessive SleepinessShift-work Disorder

Locations

Clinical Research Site

Auburn, Alabama 36832

United States

Clinical Research Site

Cullman, Alabama 35055

United States

Clinical Research Site

Chandler, Arizona 85224

United States

Clinical Research Site

Tucson, Arizona 85704

United States

Clinical Research Site

Little Rock, Arkansas 72211

United States

Clinical Research Site

Anaheim, California 92801

United States

Clinical Research Site

Cerritos, California 90703

United States

Clinical Research Site

Chula Vista, California 91910

United States

Clinical Research Site

Huntington Beach, California 92647

United States

Clinical Research Site

Long Beach, California 90805

United States

Clinical Research Site

Santa Ana, California 92705

United States

Clinical Research Site

Colorado Springs, Colorado 80918

United States

Clinical Research Site

Brandon, Florida 33511

United States

Clinical Research Site

Hialeah, Florida 33016

United States

Clinical Research Site

Miami, Florida 33135

United States

Clinical Research Site

Miami, Florida 33144

United States

Clinical Research Site

Miami, Florida 33176

United States

Clinical Research Site

Miami Lakes, Florida 33016

United States

Clinical Research Site

Atlanta, Georgia 30238

United States

Clinical Research Site

Stockbridge, Georgia 30281

United States

Clinical Research Site

Chicago, Illinois 60634

United States

Clinical Research Site

Kenner, Louisiana 70065

United States

Clinical Research Site

Towson, Maryland 21286

United States

Clinical Research Site

Boston, Massachusetts 02115

United States

Clinical Research Site

Lansing, Michigan 48911

United States

Clinical Research Site

Novi, Michigan 48377

United States

Clinical Research Site

Southfield, Michigan 48075

United States

Clinical Research Site

Chesterfield, Missouri 63017

United States

Clinical Research Site

St Louis, Missouri 63123

United States

Clinical Research Site

Henderson, Nevada 89052

United States

Clinical Research Site

Middletown, New Jersey 07748

United States

Clinical Research Site

Denver, North Carolina 28037

United States

Clinical Research Site

Fayetteville, North Carolina 28304

United States

Clinical Research Site

Huntersville, North Carolina 28078

United States

Clinical Research Site

Cincinnati, Ohio 45212

United States

Clinical Research Site

Cincinnati, Ohio 45245

United States

Clinical Research Site

Wyomissing, Pennsylvania 19610

United States

Clinical Research Site

Charleston, South Carolina 29425

United States

Clinical Research Site

Columbia, South Carolina 29201

United States

Clinical Research Site

Houston, Texas 77058

United States

Clinical Research Site

Houston, Texas 77070

United States

Clinical Research Site

San Antonio, Texas 78229

United States

Clinical Research Site

Sugar Land, Texas 77478

United States

Clinical Research Site

Spokane, Washington 99204

United States

Clinical Research Site

Calgary, Alberta T2Z 3A6

Canada

Clinical Research Site

Markham, Ontario L3R 1A3

Canada

Clinical Research Site

Ottawa, Ontario K2C 0P7

Canada

Clinical Research Site

Toronto, Ontario M4N 4M5

Canada

Clinical Research Site

Toronto, Ontario M5S 3A3

Canada