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ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.
Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solriamfetol 150 mg | Experimental | Up to 12 weeks |
|
| Solriamfetol 300 mg | 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 number of binge eating episodes | 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-bed-301@axsome.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Recruiting | Encino | California | 91316 | United States | |
| Clinical Research Site |
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| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
| ENGAGE Study Website | View source |
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| Solriamfetol 300 mg |
| Drug |
Solriamfetol tablets, taken once daily |
|
| Placebo | Drug | Placebo tablets, taken once daily |
|
| Recruiting |
| Garden Grove |
| California |
| 92845 |
| United States |
| Clinical Research Site | Recruiting | Long Beach | California | 90806 | United States |
| Clinical Research Site | Recruiting | Newport Beach | California | 92660 | United States |
| Clinical Research Site | Terminated | San Diego | California | 92103 | United States |
| Clinical Research Site | Recruiting | Santa Ana | California | 92705 | United States |
| Clinical Research Site | Recruiting | Walnut Creek | California | 94596 | United States |
| Clinical Research Site | Recruiting | West Covina | California | 91790 | United States |
| Clinical Research Site | Recruiting | Colorado Springs | Colorado | 80910 | United States |
| Clinical Research Site | Recruiting | Cromwell | Connecticut | 06416 | United States |
| Clinical Research Site | Terminated | Clermont | Florida | 34711 | United States |
| Clinical Research Site | Recruiting | Fort Myers | Florida | 33912 | United States |
| Clinical Research Site | Recruiting | Hialeah | Florida | 33012 | United States |
| Clinical Research Site | Recruiting | Jacksonville | Florida | 32256 | United States |
| Clinical Research Site | Recruiting | Lauderhill | Florida | 33319 | United States |
| Clinical Research Site | Recruiting | Miami | Florida | 33145 | United States |
| Clinical Research Site | Recruiting | Miami | Florida | 33176 | United States |
| Clinical Research Site | Terminated | Miami Lakes | Florida | 33016 | United States |
| Clinical Research Site | Recruiting | Orlando | Florida | 32801 | United States |
| Clinical Research Site | Terminated | Orlando | Florida | 32806 | United States |
| Clinical Research Site | Recruiting | Marietta | Georgia | 30060 | United States |
| Clinical Research Site | Recruiting | Overland Park | Kansas | 66210 | United States |
| Clinical Research Site | Recruiting | Boston | Massachusetts | 02131 | United States |
| Clinical Research Site | Terminated | Methuen | Massachusetts | 01844 | United States |
| Clinical Research Site | Recruiting | Saint Charles | Missouri | 63304 | United States |
| Clinical Research Site | Recruiting | Cherry Hill | New Jersey | 08002 | United States |
| Clinical Research Site | Recruiting | Princeton | New Jersey | 08540 | United States |
| Clinical Research Site | Recruiting | Mount Kisco | New York | 10549 | United States |
| Clinical Research Site | Recruiting | New York | New York | 10128 | United States |
| Clinical Research Site | Recruiting | Raleigh | North Carolina | 27607 | United States |
| Clinical Research Site | Recruiting | Cincinnati | Ohio | 45215 | United States |
| Clinical Research Site | Recruiting | Mason | Ohio | 45040 | United States |
| Clinical Research Site | Recruiting | Middleburg Heights | Ohio | 44130 | United States |
| Clinical Research Site | Terminated | North Canton | Ohio | 44720 | United States |
| Clinical Research Site | Recruiting | Portland | Oregon | 97210 | United States |
| Clinical Research Site | Recruiting | Allentown | Pennsylvania | 18104 | United States |
| Clinical Research Site | Recruiting | Media | Pennsylvania | 19063 | United States |
| Clinical Research Site | Recruiting | Greenville | South Carolina | 29615 | United States |
| Clinical Research Site | Recruiting | North Charleston | South Carolina | 29405 | United States |
| Clinical Research Site | Recruiting | Memphis | Tennessee | 38119 | United States |
| Clinical Research Site | Recruiting | Austin | Texas | 73787 | United States |
| Clinical Research Site | Recruiting | Austin | Texas | 78731 | United States |
| Clinical Research Site | Recruiting | Dallas | Texas | 75231 | United States |
| Clinical Research Site | Recruiting | San Antonio | Texas | 78229 | United States |
| Clinical Research Site | Terminated | Draper | Utah | 84020 | United States |
| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
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