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This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Each patient will receive AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg AR08 | Experimental | 0.5 mg AR08, QD for 7 weeks |
|
| 1.0 mg AR08 | Experimental | 1.0 mg AR08, QD for 7 weeks |
|
| 2.0 mg AR08 | Experimental | 2.0 mg AR08, QD for 7 weeks |
|
| Placebo | Placebo Comparator | Placebo, QD for 7 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR08 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD-RS-IV | The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35). | Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| CGI-ADHD-S/I | CGI-ADHD-S (severity) and I (improvement) - change from Baseline. | Day 35 |
| Conners' Parent Rating Scale | Conners' Parent Rating Scale (CPRS-R-S) will be assessed through Day 49. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Downey, MD | Arbor Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Clinical Research Center, LLC | Brandenton | Florida | 34201 | United States | ||
| Clinical Neuroscience Solutions, Inc. |
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| 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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| Drug |
|
| Day 49 |
| Columbia Suicide Severity Rating Scale (C-SSRS) | Columbia Suicide Severity Rating Scale (C-SSRS) - incident rate will be assessed through Day 49. | Day 49 |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| CNS Healthcare | Orlando | Florida | 32806 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Midwest Research Group at St. Charles Psychiatric Associates | Saint Charles | Missouri | 63304 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| Bayou City Research Ltd. | Houston | Texas | 77007 | United States |
| Houston Clinical Trials | Houston | Texas | 77098 | United States |
| Neuroscience Associates | Herndon | Virginia | 20170 | United States |