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Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Sponsor: Axsome Therapeutics, Inc.
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
520
Start Date
2024-08-01
Completion Date
2026-12
Last Updated
2025-11-25
Healthy Volunteers
No
Conditions
Interventions
Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
Placebo
Placebo tablets, taken once daily
Locations (40)
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Cullman, Alabama, United States
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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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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
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Brandon, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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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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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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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Markham, Ontario, Canada
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Toronto, Ontario, Canada