Characterization of Dermal Reactions in Pediatric Patients With Attention Deficit/Hyperactivity Disorder (ADHD) Using DAYTRANA - Full Text View

Sponsor:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00434213

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Daytrana	Phase IV

Study Type:	Interventional
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).

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

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:

Contact Sensitization to Methylphenidate [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Contact sensitization to methylphenidate through skin patch testing.

Enrollment:	309
Study Start Date:	January 2007
Study Completion Date:	July 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Daytrana Methylphenidate Transdermal System (MTS) Other Name: MTS

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434213

Show 29 Study Locations

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Timothy Wilens, MD

Harvard University

More Information

Additional Information:

(FDA Recall Information) This link exits the ClinicalTrials.gov site

(FDA Medical Product Safety Alerts) This link exits the ClinicalTrials.gov site

Publications:

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).

Responsible Party:	Timothy Whitaker, M.D., Clinical Research and Development - VP of Global Clinical Medicine, Shire Pharmaceutical Development Inc.
ClinicalTrials.gov Identifier:	NCT00434213 History of Changes
Other Study ID Numbers:	SPD485-411
Study First Received:	February 12, 2007
Results First Received:	February 4, 2009
Last Updated:	January 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012