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FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) 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 ADHD.
Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solriamfetol 150 mg | Experimental | Up to 6 weeks |
|
| Solriamfetol 300 mg | Experimental | Up to 6 weeks |
|
| Placebo | Placebo Comparator | Up to 6 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 6 in the AISRS total score | Adult ADHD Investigator Symptom Report Scale (AISRS) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Encino | California | 91316 | United States | ||
| Clinical Research Site |
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| Label | URL |
|---|---|
| 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 |
|
| Garden Grove |
| California |
| 92845 |
| United States |
| Clinical Research Site | Newport Beach | California | 92660 | United States |
| Clinical Research Site | Riverside | California | 92506 | United States |
| Clinical Research Site | Santa Ana | California | 92705 | United States |
| Clinical Research Site | Sherman Oaks | California | 91403 | United States |
| Clinical Research Site | Torrance | California | 90504 | United States |
| Clinical Research Site | Walnut Creek | California | 94596 | United States |
| Clinical Research Site | Colorado Springs | Colorado | 80910 | United States |
| Clinical Research Site | Clermont | Florida | 34711 | United States |
| Clinical Research Site | Doral | Florida | 33122 | United States |
| Clinical Research Site | Gainesville | Florida | 32607 | United States |
| Clinical Research Site | Jacksonville | Florida | 32256 | United States |
| Clinical Research Site | Lauderhill | Florida | 33319 | United States |
| Clinical Research Site | Miami Lakes | Florida | 33016 | United States |
| Clinical Research Site | Orlando | Florida | 32801 | United States |
| Clinical Research Site | Marietta | Georgia | 30060 | United States |
| Clinical Research Site | Overland Park | Kansas | 66210 | United States |
| Clinical Research Site | Boston | Massachusetts | 02131 | United States |
| Clinical Research Site | Saint Charles | Missouri | 63304 | United States |
| Clinical Research Site | Lincoln | Nebraska | 68526 | United States |
| Clinical Research Site | Las Vegas | Nevada | 89102 | United States |
| Clinical Research Site | Las Vegas | Nevada | 89128 | United States |
| Clinical Research Site | Berlin | New Jersey | 08009 | United States |
| Clinical Research Site | Cherry Hill | New Jersey | 08002 | United States |
| Clinical Research Site | Princeton | New Jersey | 08540 | United States |
| Clinical Research Site | Mount Kisco | New York | 10549 | United States |
| Clinical Research Site | New York | New York | 10128 | United States |
| Clinical Research Site | Raleigh | North Carolina | 27609 | United States |
| Clinical Research Site | Cincinnati | Ohio | 45219 | United States |
| Clinical Research Site | Kettering | Ohio | 45439 | United States |
| Clinical Research Site | Oklahoma City | Oklahoma | 73116 | United States |
| Clinical Research Site | Media | Pennsylvania | 19063 | United States |
| Clinical Research Site | North Charleston | South Carolina | 29405 | United States |
| Clinical Research Site | Memphis | Tennessee | 38119 | United States |
| Clinical Research Site | Austin | Texas | 78737 | United States |
| Clinical Research Site | Bellaire | Texas | 77401 | United States |
| Clinical Research Site | Dallas | Texas | 75243 | United States |
| Clinical Research Site | Dallas | Texas | 75251 | United States |
| Clinical Research Site | San Antonio | Texas | 78229 | United States |
| Clinical Research Site | Draper | Utah | 84020 | United States |
| Clinical Research Site | Everett | Washington | 98201 | United States |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
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