RecruitingPhase 3NCT06568367

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

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


Sponsor

Axsome Therapeutics, Inc.

Enrollment

520 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a drug called Solriamfetol 150 mg, and others for people with excessive sleepiness and shift-work disorder. The study is currently recruiting participants at 40 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSolriamfetol 150 mg

Solriamfetol tablets, taken once daily

DRUGSolriamfetol 300 mg

Solriamfetol tablets, taken once daily

DRUGPlacebo

Placebo tablets, taken once daily


Locations(49)

Clinical Research Site

Auburn, Alabama, United States

Clinical Research Site

Cullman, Alabama, United States

Clinical Research Site

Chandler, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Cerritos, California, United States

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Chula Vista, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Santa Ana, California, United States

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Colorado Springs, Colorado, United States

Clinical Research Site

Brandon, Florida, United States

Clinical Research Site

Hialeah, Florida, United States

Clinical Research Site

Miami, Florida, United States

Clinical Research Site

Miami, Florida, United States

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Miami, Florida, United States

Clinical Research Site

Miami Lakes, Florida, United States

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Atlanta, Georgia, United States

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Stockbridge, Georgia, United States

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Chicago, Illinois, United States

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Kenner, Louisiana, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Lansing, Michigan, United States

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Novi, Michigan, United States

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Southfield, Michigan, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Middletown, New Jersey, United States

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Denver, North Carolina, United States

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Fayetteville, North Carolina, United States

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Huntersville, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Spokane, Washington, United States

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Calgary, Alberta, Canada

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Markham, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

Clinical Research Site

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06568367


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