Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
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ClinicalTrials.gov Identifier: NCT00434213 |
Recruitment Status
:
Completed
First Posted
: February 13, 2007
Results First Posted
: March 6, 2009
Last Update Posted
: April 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Attention Deficit Hyperactivity Disorder | Drug: Daytrana | Phase 4 |
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 |

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

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Ages Eligible for Study: | 6 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434213

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 |
Principal Investigator: | Timothy Wilens, MD | Harvard Medical School |
Publications of Results:
Responsible Party: | Noven Therapeutics |
ClinicalTrials.gov Identifier: | NCT00434213 History of Changes |
Other Study ID Numbers: |
SPD485-411 |
First Posted: | February 13, 2007 Key Record Dates |
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 |