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The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate. | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination. | Throughout the study period of approximately 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter. | Baseline, Weekly for 4 weeks, and then Monthly for 5 months. | |
| Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET). | Baseline, Weekly for 4 weeks, and then Monthly for 5 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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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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| ID | Term |
|---|---|
| D000661 | Amphetamine |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET. | Baseline, Weekly for 4 weeks, and then Monthly for 5 months. |
| Organic Chemicals |