Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase IV, Multi-center, Open-label Study of DAYTRANA (Methylphenidate Transdermal System [MTS]) to Characterize the Dermal Reactions in Pediatric Patients Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD).

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Daytrana


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must sign informed consent. Male or female 6-12 years old. Negative pregnancy test. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD. No co-morbid illness that could affect safety, tolerability or interfere with participation. Blood pressure (BP) within the 95th percentile for age, gender, and height. Willing and able to comply with all the requirements defined in protocol. Exclusion Criteria: Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder [ODD]). At risk for suicidal or violent behavior towards self or others. History of a suicide attempt. History of a structural cardiac abnormality or other serious cardiac problems. Non-responder to psychostimulant treatment. Is overweight. Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder. Has Conduct Disorder. Known history of alcohol or other substance abuse within the last 6 months. Any abnormal thyroid function. A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments. Has had treatment with any known liver altering agents within 30 days prior to Screening. Taking any excluded medication. Previous use of DAYTRANA. Taking other medications that have Central Nervous System (CNS) effects. Female subject is pregnant or lactating. Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions. Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives. Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites. A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate Transdermal System<br>To characterize the dermal reactions seen with the use of DAYTRANA | Drug: Daytrana<br>* Methylphenidate Transdermal System (MTS)<br>* Other names: MTS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Sensitization to Methylphenidate | Contact sensitization to methylphenidate through skin patch testing. | 7 weeks |