Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noven Therapeutics
• Treatments: Methylphenidate

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.