Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

Completed · Phase 4

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT00434213

Run by

Noven Therapeutics

People needed

309

Starts

2007-01-01

Expected to finish

2008-07-01

Last updated by the study team

2017-04-26

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Irvine, California, United States
• Study site — San Marcos, California, United States
• Study site — Spring Valley, California, United States
• Study site — Wildomar, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Libertyville, Illinois, United States
• Study site — Northbrook, Illinois, United States
• Study site — Overland Park, Kansas, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Owensboro, Kentucky, United States
• Study site — Cambridge, Massachusetts, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Toms River, New Jersey, United States
• Study site — Rochester, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Salem, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Jackson, Tennessee, United States

Full record on ClinicalTrials.gov

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