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The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-089 | Drug | Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADHD-RS-IV (HV) | Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 | |
| CGI-ADHD-S | Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Gault, M.D., Ph.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref #/Investigator 6800 | Little Rock | Arkansas | 72205 | United States | ||
| Site Ref #/Investigator 6812 |
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| Boulder |
| Colorado |
| 80304 |
| United States |
| Site Ref #/Investigator 8366 | Bradenton | Florida | 34208 | United States |
| Site Ref #/Investigator 6808 | Jacksonville | Florida | 32216 | United States |
| Site Ref #/Investigator 6827 | Orlando | Florida | 32806 | United States |
| Site Ref #/Investigator 8383 | Libertyville | Illinois | 60048 | United States |
| Site Ref #/Investigator 6802 | Northbrook | Illinois | 60062 | United States |
| Site Ref #/Investigator 6824 | Overland Park | Kansas | 66212 | United States |
| Site Ref #/Investigator 8428 | Troy | Michigan | 48085 | United States |
| Site Ref #/Investigator 6902 | Omaha | Nebraska | 68198 | United States |
| Site Ref #/Investigator 6856 | Las Vegas | Nevada | 89128 | United States |
| Site Ref #/Investigator 6683 | Clementon | New Jersey | 08021 | United States |
| Site Ref #/Investigator 8297 | Oklahoma City | Oklahoma | 73103 | United States |
| Site Ref #/Investigator 6682 | Eugene | Oregon | 97401 | United States |
| Site Ref #/Investigator 6811 | Portland | Oregon | 97210 | United States |
| Site Ref #/Investigator 8701 | Portland | Oregon | 97210 | United States |
| Site Ref #/Investigator 6681 | Salem | Oregon | 97301 | United States |
| Site Ref #/Investigator 6799 | Charleston | South Carolina | 29405 | United States |
| Site Ref #/Investigator 7955 | Memphis | Tennessee | 38119 | United States |
| Site Ref #/Investigator 6836 | Austin | Texas | 78756 | United States |
| Site Ref #/Investigator 6835 | Herndon | Virginia | 20170 | United States |
| Site Ref #/Investigator 6791 | Bellevue | Washington | 98007 | United States |
| Site Ref #/Investigator 6838 | Middleton | Wisconsin | 53562 | 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 |
|---|---|
| C108326 | pozanicline |
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