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This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPN-810 | Drug | administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in aggressive behavior as assessed by R-MOAS score | Change from baseline to Visit 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs | Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs | Visit 2 to End of Study |
| Change in CGI-S |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dothan | Alabama | United States | ||||
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| Placebo |
| Drug |
administered orally |
|
| Baseline to Visit 5 |
| CGI-I score at each post-baseline Visit | Baseline to Visit 5 |
| Change in SNAP-IV ADHD scores | Baseline to Visit 5 |
| Los Angeles |
| California |
| United States |
| Santa Ana | California | United States |
| Washington D.C. | District of Columbia | United States |
| Bradenton | Florida | United States |
| Gainesville | Florida | United States |
| Hialeah | Florida | United States |
| Jacksonville | Florida | United States |
| Maitland | Florida | United States |
| North Miami | Florida | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Libertyville | Illinois | United States |
| Indianapolis | Indiana | United States |
| Terre Haute | Indiana | United States |
| Owensboro | Kentucky | United States |
| Toms River | New Jersey | United States |
| Stony Brook | New York | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Memphis | Tennessee | United States |
| Bellevue | Washington | United States |
| Bothell | Washington | 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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