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| Name | Class |
|---|---|
| Noven Pharmaceuticals, Inc. | INDUSTRY |
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This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate Transdermal System | Active Comparator | Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks |
|
| Placebo patch | Placebo Comparator | Placebo patch applied daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Drug | To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score on ADHD Rating Scale at 4 weeks | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Parent rating scale | 30 days | |
| Parent Global Assessment | 30 days | |
| Medication Satisfaction Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meadowbrook Research, Inc. | Scottsdale | Arizona | United States | |||
| Psychiatric Centers at San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20003260 | Derived | Bukstein OG, Arnold LE, Landgraf JM, Hodgkins P. Does switching from oral extended-release methylphenidate to the methylphenidate transdermal system affect health-related quality-of-life and medication satisfaction for children with attention-deficit/hyperactivity disorder? Child Adolesc Psychiatry Ment Health. 2009 Dec 10;3(1):39. doi: 10.1186/1753-2000-3-39. | |
| 19916704 |
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|
| 30 days |
| ADHD Impact Module | 30 days |
| Clinical Global Impressions Scale | 30 days |
| Adverse events, lab tests, dermal evaluations, ECGs | 30 days |
| San Marcos |
| California |
| United States |
| Alpine Clinical Research Center | Boulder | Colorado | United States |
| Miami Research Associates, Inc. | Miami | Florida | United States |
| Capstone Clinical Research | Libertyville | Illinois | United States |
| Pedia Research, LLC | Owensboro | Kentucky | United States |
| ProMed Pediatrics | Kalamazoo | Michigan | United States |
| Children's Specialized Hospital | Toms River | New Jersey | United States |
| North Carolina Neuropsychiatry PA | Chapel Hill | North Carolina | United States |
| Ohio State University | Columbus | Ohio | United States |
| IPS Research Company | Oklahoma City | Oklahoma | United States |
| Oregon Center for Clinical Investigations (OCCI, Inc.) | Portland | Oregon | United States |
| CNS Research Institute | Philadelphia | Pennsylvania | United States |
| Western Psychiatric Institute & Clinic | Pittsburgh | Pennsylvania | United States |
| Claghorn-Lesem Research Clinic | Bellaire | Texas | United States |
| ADHD Clinic of San Antonio | San Antonio | Texas | United States |
| NeuroScience, Inc. | Herndon | Virginia | United States |
| Monarch Medical Research | Norfolk | Virginia | United States |
| Arnold LE, Bozzolo DR, Hodgkins P, McKay M, Beckett-Thurman L, Greenbaum M, Bukstein O, Patel A. Switching from oral extended-release methylphenidate to the methylphenidate transdermal system: continued attention-deficit/hyperactivity disorder symptom control and tolerability after abrupt conversion. Curr Med Res Opin. 2010 Jan;26(1):129-37. doi: 10.1185/03007990903437412. |
| 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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