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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00434213
First received: February 12, 2007
Last updated: January 3, 2011
Last verified: January 2011

February 12, 2007
January 3, 2011
January 2007
August 2007   (final data collection date for primary outcome measure)
Dermal Reactions [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
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.
To characterize the dermal reactions seen with the use of DAYTRANA. Dermal Assessments will be done once per week during office visit.
Complete list of historical versions of study NCT00434213 on ClinicalTrials.gov Archive Site
Contact Sensitization to Methylphenidate [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Contact sensitization to methylphenidate through skin patch testing.
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.
Not Provided
Not Provided
 
Characterization of Dermal Reactions in Pediatric Patients With Attention Deficit/Hyperactivity Disorder (ADHD) Using DAYTRANA
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).

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
Drug: Daytrana
Methylphenidate Transdermal System (MTS)
Other Name: MTS
Experimental: 1
Intervention: Drug: Daytrana
Warshaw EM, Squires L, Li Y, et al. Methylphenidate Transdermal System: A Multisite, Open-Label Study of Dermal Reactions in Pediatric Patients Diagnosed With ADHD. Primary Care Companion Journal Clinical Psychiatry; 12(6): e1-e9, 2010 (published online).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
309
July 2008
August 2007   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00434213
SPD485-411
Not Provided
Timothy Whitaker, M.D., Clinical Research and Development - VP of Global Clinical Medicine, Shire Pharmaceutical Development Inc.
Shire
Not Provided
Principal Investigator: Timothy Wilens, MD Harvard Medical School
Shire
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP