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This study was stopped by the sponsor before enrollment based on a non-safety related corporate decision.
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The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD465 then Placebo | Experimental |
| |
| Placebo then SPD465 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD465 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit. | Interim visit = Week 3; Final visit = Week 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Interim & final visits: Attention-Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) | Interim visit = Week 3; Final visit = Week 7. | |
| Interim & final visits: Clinical Global Impressions of Improvement (CGI-I) | Interim visit = Week 3; Final visit = Week 7. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meridien Research | Tampa | Florida | United States |
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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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| Other |
Placebo is a material that may look similar to SPD465, however, contains no active drug. |
|
| Interim & final visits: Self-Rating of Simulated Driver Safety (DS) Performance Questionnaire | Post DS Testing - Interim visit = Week 3; Post DS Testing - Final visit = Week 7. |