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The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | NRP104 |
|
| 2 | Active Comparator | Adderall XR |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRP104 | Drug | 30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| SKAMP-DS scores across a treatment assessment day | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day | 1 week | |
| Treatment emergent adverse events | 1 week | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Biederman, M.D. | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Samuel Boellner, M.D. | Clinical Study Centers, LLC | Principal Investigator |
| Ann Childress, M.D. | Center for Psychiatry And Behavioral Medicine Inc. | Principal Investigator |
| Frank Lopez, M.D. | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17631866 | Result | Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007 Nov 1;62(9):970-6. doi: 10.1016/j.biopsych.2007.04.015. Epub 2007 Jul 12. | |
| 20215923 |
| Label | URL |
|---|---|
| FDA Recall information | View source |
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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 |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| C449521 | SLI381 |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| Adderall XR | Drug | 10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg |
|
|
| Placebo | Drug | Placebo capsule taken once daily in the morning |
|
| PK profile and PK/PD relationship of NRP104 |
| After multiple doses |
| Faraone SV, Spencer TJ, Kollins SH, Glatt SJ. Effects of lisdexamfetamine dimesylate treatment for ADHD on growth. J Am Acad Child Adolesc Psychiatry. 2010 Jan;49(1):24-32. doi: 10.1097/00004583-201001000-00006. |
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |