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Multi-Center, Open-Label Study, Characterization of Dermal Reactions in Pediatric Patients Aged 6-12 With ADHD Using DAYTRANA
This study has been completed.
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: MTS
Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
Drug Information available for: Methylphenidate hydrochloride Methylphenidate
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:
  • To characterize the dermal reactions seen with the use of DAYTRANA. Dermal Assessments will be done once per week during office visit.

Secondary Outcome Measures:
  • To identify sensitization through skin patch testing in those subjects whose dermal response scores are observed to be => 6 and also those subjects whose DRS persist at =>4.

Enrollment: 309
Study Start Date: January 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: 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 DSM-IV-TR criteria for a primary diagnosis of ADHD.
  • No co-morbid illness that could affect safety, tolerability or interfere with participation.
  • 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 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 medi- cations that have 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

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
Last Updated: August 22, 2008
ClinicalTrials.gov Identifier: NCT00434213  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009