Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: Daytrana	Phase 4

Detailed Description:

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	309 participants
Intervention Model:	Single Group Assignment
Masking:	None (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).
Study Start Date :	January 2007
Actual Primary Completion Date :	August 2007
Actual Study Completion Date :	July 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Methylphenidate Transdermal System; To characterize the dermal reactions seen with the use of DAYTRANA	Drug: Daytrana; Methylphenidate Transdermal System (MTS); Other Name: MTS

Outcome Measures

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Primary Outcome Measures :

1. Dermal Reactions [ Time Frame: 7 weeks ]
   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 :

1. Contact Sensitization to Methylphenidate [ Time Frame: 7 weeks ]
   Contact sensitization to methylphenidate through skin patch testing.

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 12 Years (Child)
Sexes Eligible for Study:	All
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

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Locations

United States, Arizona
Scottsdale, Arizona, United States
United States, California
Irvine, California, United States
San Marcos, California, United States
Spring Valley, California, United States
Wildomar, California, United States
United States, Colorado
Boulder, Colorado, United States
United States, Florida
Gainesville, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
United States, Illinois
Libertyville, Illinois, United States
Northbrook, Illinois, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Kentucky
Bardstown, Kentucky, United States
Owensboro, Kentucky, United States
United States, Massachusetts
Cambridge, Massachusetts, United States
United States, Michigan
Kalamazoo, Michigan, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Tom's River, New Jersey, United States
United States, New York
Rochester, New York, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Oregon
Portland, Oregon, United States
Salem, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Jackson, Tennessee, United States
United States, Texas
Austin, Texas, United States
Lubbock, Texas, United States, 79423
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States

Sponsors and Collaborators

Noven Therapeutics

Investigators

Principal Investigator:	Timothy Wilens, MD	Harvard Medical School

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Warshaw EM, Squires L, Li Y, Civil R, Paller AS. Methylphenidate transdermal system: a multisite, open-label study of dermal reactions in pediatric patients diagnosed with ADHD. Prim Care Companion J Clin Psychiatry. 2010;12(6). pii: PCC.10m00996. doi: 10.4088/PCC.10m00996pur.

Responsible Party:	Noven Therapeutics
ClinicalTrials.gov Identifier:	NCT00434213 History of Changes
Other Study ID Numbers:	SPD485-411
First Posted:	February 13, 2007
Results First Posted:	March 6, 2009
Last Update Posted:	April 26, 2017
Last Verified:	March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms	Methylphenidate; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents