Clinical trial NCT00434213: Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 309
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Dermal Reactions
timeFrame: 7 weeks
Secondary outcomes:
measure: Contact Sensitization to Methylphenidate
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Irvine
country: United States
state: California
city: San Marcos
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Libertyville
country: United States
state: Illinois
city: Northbrook
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Cambridge
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Tom's River
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Jackson
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Timothy Wilens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):PCC.10m00996. doi: 10.4088/PCC.10m00996pur.