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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solriamfetol 150mg | Experimental | Up to 12 weeks |
|
| Solriamfetol 300mg | Experimental | Up to 12 weeks |
|
| Placebo | Placebo Comparator | Up to 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solriamfetol 150 mg | Drug | Solriamfetol tablets, taken once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT). | 12 weeks | |
| Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 212-332-5061 | sol-swd-301@axsome.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Recruiting | Cullman | Alabama | 35055 | United States | |
| Clinical Research Site |
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| Label | URL |
|---|---|
| SUSTAIN Study Website | View source |
| Axsome Therapeutics Website | View source |
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| Solriamfetol 300 mg |
| Drug |
Solriamfetol tablets, taken once daily |
|
| Placebo | Drug | Placebo tablets, taken once daily |
|
| Recruiting |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Clinical Research Site | Recruiting | Tucson | Arizona | 85704 | United States |
| Clinical Research Site | Recruiting | Little Rock | Arkansas | 72211 | United States |
| Clinical Research Site | Recruiting | Cerritos | California | 90703 | United States |
| Clinical Research Site | Recruiting | Chula Vista | California | 91910 | United States |
| Clinical Research Site | Recruiting | Huntington Beach | California | 92647 | United States |
| Clinical Research Site | Recruiting | Long Beach | California | 90805 | United States |
| Clinical Research Site | Recruiting | Santa Ana | California | 92705 | United States |
| Clinical Research Site | Recruiting | Colorado Springs | Colorado | 80918 | United States |
| Clinical Research Site | Recruiting | Brandon | Florida | 33511 | United States |
| Clinical Research Site | Recruiting | Hialeah | Florida | 33016 | United States |
| Clinical Research Site | Recruiting | Miami | Florida | 33135 | United States |
| Clinical Research Site | Recruiting | Miami | Florida | 33144 | United States |
| Clinical Research Site | Recruiting | Miami | Florida | 33176 | United States |
| Clinical Research Site | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Clinical Research Site | Recruiting | Atlanta | Georgia | 30238 | United States |
| Clinical Research Site | Recruiting | Stockbridge | Georgia | 30281 | United States |
| Clinical Research Site | Recruiting | Towson | Maryland | 21286 | United States |
| Clinical Research Site | Recruiting | Boston | Massachusetts | 02115 | United States |
| Clinical Research Site | Recruiting | Lansing | Michigan | 48911 | United States |
| Clinical Research Site | Recruiting | Novi | Michigan | 48377 | United States |
| Clinical Research Site | Recruiting | Southfield | Michigan | 48075 | United States |
| Clinical Research Site | Recruiting | Chesterfield | Missouri | 63017 | United States |
| Clinical Research Site | Recruiting | St Louis | Missouri | 63123 | United States |
| Clinical Research Site | Recruiting | Henderson | Nevada | 89052 | United States |
| Clinical Research Site | Recruiting | Middletown | New Jersey | 07748 | United States |
| Clinical Research Site | Recruiting | Denver | North Carolina | 28037 | United States |
| Clinical Research Site | Recruiting | Fayetteville | North Carolina | 28304 | United States |
| Clinical Research Site | Recruiting | Huntersville | North Carolina | 28078 | United States |
| Clinical Research Site | Recruiting | Cincinnati | Ohio | 45212 | United States |
| Clinical Research Site | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Clinical Research Site | Recruiting | Wyomissing | Pennsylvania | 19610 | United States |
| Clinical Research Site | Recruiting | Charleston | South Carolina | 29425 | United States |
| Clinical Research Site | Recruiting | Columbia | South Carolina | 29201 | United States |
| Clinical Research Site | Recruiting | Houston | Texas | 77070 | United States |
| Clinical Research Site | Recruiting | San Antonio | Texas | 78229 | United States |
| Clinical Research Site | Recruiting | Sugar Land | Texas | 77478 | United States |
| Clinical Research Site | Recruiting | Markham | Ontario | L3R 1A3 | Canada |
| Clinical Research Site | Recruiting | Toronto | Ontario | M5S 3A3 | Canada |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D021081 | Chronobiology Disorders |
| D009784 | Occupational Diseases |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
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