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

Sponsored by:	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

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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).

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Dermal Reactions [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Contact Sensitization to Methylphenidate [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

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
1: Experimental	Drug: Daytrana Methylphenidate Transdermal System (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 30 Study Locations

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Timothy Wilens, MD

Harvard University

More Information

No publications provided

Responsible Party:	Shire Pharmaceutical Development Inc. ( Timothy Whitaker, M.D., Clinical Research and Development - VP of Global Clinical Medicine )
Study ID Numbers:	SPD485-411
Study First Received:	February 12, 2007
Results First Received:	February 4, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00434213 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Signs and Symptoms

Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009