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Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
This study has been completed.
Sponsor:
Noven Therapeutics
Information provided by (Responsible Party):
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT00434213
First received: February 12, 2007
Last updated: March 27, 2017
Last verified: March 2017
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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.
| Condition | Intervention | Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Drug: Daytrana | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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). |
Resource links provided by NLM:
Further study details as provided by Noven Therapeutics:
Primary Outcome Measures:
- 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:
- Contact Sensitization to Methylphenidate [ Time Frame: 7 weeks ]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: Methylphenidate Transdermal System
To characterize the dermal reactions seen with the use of DAYTRANA
|
Drug: Daytrana
Methylphenidate Transdermal System (MTS)
Other Name: MTS
|
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.
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434213
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00434213
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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
Publications:
| Responsible Party: | Noven Therapeutics |
| 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: | March 27, 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 |
ClinicalTrials.gov processed this record on September 21, 2017