Characterization of Dermal Reactions in Pediatric Patients With Attention Deficit/Hyperactivity Disorder (ADHD) Using DAYTRANA
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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).|
- Dermal Reactions [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]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.
- Contact Sensitization to Methylphenidate [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]Contact sensitization to methylphenidate through skin patch testing.
|Study Start Date:||January 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Methylphenidate Transdermal System (MTS)
Other Name: MTS
Show 29 Study Locations
|Principal Investigator:||Timothy Wilens, MD||Harvard Medical School|