Axsome Therapeutics, Inc.
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).
Excessive Sleepiness
Shift-work Disorder
Solriamfetol 150 mg
Solriamfetol 300 mg
Placebo
PHASE3
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 520 participants |
Masking : | DOUBLE |
Primary Purpose : | TREATMENT |
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 |
Actual Study Start Date : | 2024-08-01 |
Estimated Primary Completion Date : | 2026-12 |
Estimated Study Completion Date : | 2026-12 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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Clinical Research Site
Little Rock, Arkansa, United States, 72211
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Clinical Research Site
Cerritos, California, United States, 90703
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Clinical Research Site
Chula Vista, California, United States, 91910
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Clinical Research Site
Long Beach, California, United States, 90805
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Clinical Research Site
Santa Anna, California, United States, 92705
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Clinical Research Site
Colorado Springs, Colorado, United States, 80918
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Clinical Research Site
Hialeah, Florida, United States, 33016
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Clinical Research Site
Miami, Florida, United States, 33144
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Clinical Research Site
Miami, Florida, United States, 33176
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Clinical Research Site
Miami, Florida, United States, 33186
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Clinical Research Site
Miami Lakes, Florida, United States, 33016
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Clinical Research Site
Atlanta, Georgia, United States, 30238
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Clinical Research Site
Stockbridge, Georgia, United States, 30281
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Lathrup Village, Road cancer, United States, 48076
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Novi, Road cancer, United States, 48377
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Clinical Research Site
Chesterfield, Missouri, United States, 63017
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Clinical Research Site
St louis, Missouri, United States, 63123
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Clinical Research Site
Denver, North Carolina, United States, 28037
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Clinical Research Site
Huntersville, North Carolina, United States, 28078
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Clinical Research Site
Cincinnati, Ohio, United States, 45212
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Clinical Research Site
Cincinnati, Ohio, United States, 45245
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Clinical Research Site
Wyomissing, Pennsylvania, United States, 19610
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Clinical Research Site
Charleston, South Carolina, United States, 29425
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Clinical Research Site
Columbia, South Carolina, United States, 29201
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Clinical Research Site
San Antonio, Texas, United States, 78229