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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).
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.
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.
Age
6 - 12 years
Sex
ALL
Healthy Volunteers
No
Scottsdale, Arizona, United States
Irvine, California, United States
San Marcos, California, United States
Spring Valley, California, United States
Wildomar, California, United States
Boulder, Colorado, United States
Gainesville, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
Libertyville, Illinois, United States
Start Date
January 1, 2007
Primary Completion Date
August 1, 2007
Completion Date
July 1, 2008
Last Updated
April 26, 2017
309
ACTUAL participants
Daytrana
DRUG
Lead Sponsor
Noven Therapeutics
NCT07189442
NCT06123741
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06847165