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The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.
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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,I-amphetamine aspartate monohydrate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| PERMP (Permanent Product Measure of Performance) | 0.5 hours pre-dosing | |
| PERMP (Permanent Product Measure of Performance) | 2 hours post-dosing | |
| PERMP (Permanent Product Measure of Performance) | 4 hours post-dosing | |
| PERMP (Permanent Product Measure of Performance) | 8 hours post-dosing | |
| PERMP (Permanent Product Measure of Performance) | 12 hours post-dosing | |
| PERMP (Permanent Product Measure of Performance) | 14 hours post-dosing | |
| PERMP (Permanent Product Measure of Performance) | 16 hours post-dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time Segment Rating System (ADHD-RS[TSRS]) | 5½, 11, and 16½ hours post-dosing | |
| Subject self report (ADHD-SRS) of ADHD | approximately 5½, 11, and 16½ hours post-dosing | |
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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 |
|---|---|---|---|---|---|---|
| Clinical Study Center | Little Rock | Arkansas | United States | |||
| UCI Child Development Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29087231 | Derived | Wigal T, Childress A, Frick G, Yan B, Wigal S, Madhoo M. Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment. Postgrad Med. 2018 Jan;130(1):111-121. doi: 10.1080/00325481.2018.1389227. Epub 2017 Oct 31. |
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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 |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Treatment emergent adverse events |
| Throughout the study period of approximately 3.25 months. |
| Modified Pittsburgh Sleep Quality Index (PSQI) | Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit |
| Irvine |
| California |
| United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | United States |
| Bayou City Research, Ltd. | Houston | Texas | United States |
| Organic Chemicals |