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Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molindone | Other | Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molindone | Drug | The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD | Safety Assessments include: Adverse Events, clinical lab tests, vital signs, physical examinations, ECGs, Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS) and Columbia Suicise Severity Rating Scale (C-SSRS) | over 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of 810M | Secondary efficacy endpoints: Retrospective-Modified Overt Aggression Scale (R-MOAS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I), Swanson, Nolan and Pelman Rating Scale-Revised (SNAP-IV) ADHD scale scores | over 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dothan | Alabama | United States | ||||
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|
| Los Angeles |
| California |
| United States |
| Santa Ana | California | United States |
| Wildomar | 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 |
|---|---|
| D008972 | Molindone |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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