Characterization of Dermal Reactions in Pediatric Patients With Attention Deficit/Hyperactivity Disorder (ADHD) Using DAYTRANA
This study has been completed.
Information provided by:
Shire Development LLC
First received: February 12, 2007
Last updated: January 3, 2011
Last verified: January 2011
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.
Attention Deficit Hyperactivity Disorder
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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).
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2007 (Final data collection date for primary outcome measure)
Methylphenidate Transdermal System (MTS)
Other Name: MTS
|Ages Eligible for Study:
||6 Years to 12 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434213
Shire Development LLC
||Timothy Wilens, MD
||Harvard Medical School
Warshaw EM, Squires L, Li Y, et al. Methylphenidate Transdermal System: A Multisite, Open-Label Study of Dermal Reactions in Pediatric Patients Diagnosed With ADHD. Primary Care Companion Journal Clinical Psychiatry; 12(6): e1-e9, 2010 (published online).
||Timothy Whitaker, M.D., Clinical Research and Development - VP of Global Clinical Medicine, Shire Pharmaceutical Development Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 12, 2007
|Results First Received:
||February 4, 2009
||January 3, 2011
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Signs and Symptoms
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents