Multi-Center, Open-Label Study, Characterization of Dermal Reactions in Pediatric Patients Aged 6-12 With ADHD Using DAYTRANA

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Methylphenidate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Shire Pharmaceutical Development

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).

Study design: Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To characterize the dermal reactions seen with the use of DAYTRANA. Dermal Assessments will be done once per week during office visit.

Secondary outcome: To identify sensitization through skin patch testing in those subjects whose dermal response scores are observed to be => 6 and also those subjects whose DRS persist at =>4.

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Must sign informed consent. Male or female 6-12 years old. Negative pregnancy test. Meet DSM-IV-TR criteria for a primary diagnosis of ADHD. No co-morbid illness that could affect safety, tolerability or interfere with participation. 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 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 medi- cations that have 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.

Lubbock, Texas 79423, United States

Starting date: January 2007
Ending date: July 2007
Last updated: November 5, 2007