Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

NCT ID: NCT00434213

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-07-31

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylphenidate Transdermal System

To characterize the dermal reactions seen with the use of DAYTRANA

Group Type: EXPERIMENTAL

Daytrana

Intervention Type: DRUG

Methylphenidate Transdermal System (MTS)

Interventions

Daytrana

Methylphenidate Transdermal System (MTS)

Intervention Type: DRUG

Other Intervention Names

MTS

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noven Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Wilens, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

Scottsdale, Arizona, United States

Irvine, California, United States

San Marcos, California, United States

Spring Valley, California, United States

Wildomar, California, United States

Boulder, Colorado, United States

Gainesville, Florida, United States

Miami, Florida, United States

Winter Park, Florida, United States

Libertyville, Illinois, United States

Northbrook, Illinois, United States

Overland Park, Kansas, United States

Bardstown, Kentucky, United States

Owensboro, Kentucky, United States

Cambridge, Massachusetts, United States

Kalamazoo, Michigan, United States

Las Vegas, Nevada, United States

Toms River, New Jersey, United States

Rochester, New York, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Portland, Oregon, United States

Salem, Oregon, United States

Philadelphia, Pennsylvania, United States

Jackson, Tennessee, United States

Austin, Texas, United States

Lubbock, Texas, United States

San Antonio, Texas, United States

Norfolk, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21494336 (View on PubMed)

Other Identifiers

SPD485-411

Identifier Type: -

Identifier Source: org_study_id