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| Name | Class |
|---|---|
| Noven Pharmaceuticals, Inc. | INDUSTRY |
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This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate Transdermal System | Active Comparator | The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening. |
|
| Placebo | Placebo Comparator | The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening. |
|
| Concerta | Active Comparator | CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Drug | MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes |
|
| Measure | Description | Time Frame |
|---|---|---|
| SKAMP deportment rating scale | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| PERMP age-adjusted math test | Week 8 | |
| Clinician-rated ADHD-RS-IV | Week 8 | |
| CGI-I |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18434918 | Background | Wilens TE, Boellner SW, Lopez FA, Turnbow JM, Wigal SB, Childress AC, Abikoff HB, Manos MJ. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):700-708. doi: 10.1097/CHI.0b013e31816bffdf. | |
| 20973706 | Derived |
| 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 |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily |
|
|
| Concerta | Drug | CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily |
|
|
| Week 8 |
| Parent Global Assessment | Week 8 |
| Connors' Parent Rating Scale | Week 8 |
| ADHD Impact Module-Children | Week 8 |
| SKAMP-total and inattention subscales | Week 8 |
| Frazier TW, Weiss M, Hodgkins P, Manos MJ, Landgraf JM, Gibbins C. Time course and predictors of health-related quality of life improvement and medication satisfaction in children diagnosed with attention-deficit/hyperactivity disorder treated with the methylphenidate transdermal system. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):355-64. doi: 10.1089/cap.2009.0092. |
| 19849639 | Derived | Manos M, Frazier TW, Landgraf JM, Weiss M, Hodgkins P. HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system. Curr Med Res Opin. 2009 Dec;25(12):3001-10. doi: 10.1185/03007990903388797. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |