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This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks.
This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks. Subjects will be titrated to an optimum dose of study treatment and assessed for safety and efficacy. Dermal response will be evaluated at each visit by the investigator. Subjects with high dermal response scores or scores that persist at the same application site and have no improvement after up to 4 evaluations (not to exceed a two week period) will be discontinued from the study and referred to a study specific dermatologist for specialized skin sensitivity skin patch testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate Transdermal System | Experimental | To characterize the dermal reactions seen with the use of DAYTRANA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daytrana | Drug | Methylphenidate Transdermal System (MTS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dermal Reactions | Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Contact Sensitization to Methylphenidate | Contact sensitization to methylphenidate through skin patch testing. | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Wilens, MD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21494336 | Result | Warshaw EM, Squires L, Li Y, Civil R, Paller AS. Methylphenidate transdermal system: a multisite, open-label study of dermal reactions in pediatric patients diagnosed with ADHD. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00996. doi: 10.4088/PCC.10m00996pur. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daytrana | Methylphenidate Transdermal System (MTS) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Irvine |
| California |
| United States |
| San Marcos | California | United States |
| Spring Valley | California | United States |
| Wildomar | California | United States |
| Boulder | Colorado | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Winter Park | Florida | United States |
| Libertyville | Illinois | United States |
| Northbrook | Illinois | United States |
| Overland Park | Kansas | United States |
| Bardstown | Kentucky | United States |
| Owensboro | Kentucky | United States |
| Cambridge | Massachusetts | United States |
| Kalamazoo | Michigan | United States |
| Las Vegas | Nevada | United States |
| Toms River | New Jersey | United States |
| Rochester | New York | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Portland | Oregon | United States |
| Salem | Oregon | United States |
| Philadelphia | Pennsylvania | United States |
| Jackson | Tennessee | United States |
| Austin | Texas | United States |
| Lubbock | Texas | 79423 | United States |
| San Antonio | Texas | United States |
| Norfolk | Virginia | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daytrana | Methylphenidate Transdermal System (MTS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dermal Reactions | Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. | Safety population | Posted | Number | Participants | 7 weeks |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Contact Sensitization to Methylphenidate | Contact sensitization to methylphenidate through skin patch testing. | Safety population | Posted | Number | Participants | 7 weeks |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daytrana | Methylphenidate Transdermal System (MTS) | 0 | 305 | 242 | 305 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Affect lability | Psychiatric disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after SPONSOR confirms there shall be no multicenter Study publication, the INSTITUTION and/or such PRINCIPAL INVESTIGATOR may publish the results from the INSTITUTION site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amaury Sanchez, Sr. Manager, Regulatory Affairs | Noven Pharmaceuticals, Inc. | asanchez@noven.com |
| 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 |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
|
| 3 (erythema and papules) |
|
| 4 (definite edema) |
|
| 5 (erythema, edema, and papules) |
|
| 6 (vesicular eruption) |
|
| 7 (strong reaction beyond test site) |
|
| No dermal evaluation |
|
|