Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Daytrana
Intervention description: Methylphenidate Transdermal System (MTS)
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 309.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

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.
    

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.