Characterization of Dermal Reactions in Pediatric Patients With 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).
1 other identifier
interventional
309
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2007
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 12, 2007
CompletedFirst Posted
Study publicly available on registry
February 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
March 6, 2009
CompletedApril 26, 2017
March 1, 2017
7 months
February 12, 2007
February 4, 2009
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Dermal Reactions
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.
7 weeks
Secondary Outcomes (1)
Contact Sensitization to Methylphenidate
7 weeks
Study Arms (1)
Methylphenidate Transdermal System
EXPERIMENTALTo characterize the dermal reactions seen with the use of DAYTRANA
Interventions
Methylphenidate Transdermal System (MTS)
Eligibility Criteria
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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
San Marcos, California, United States
Unknown Facility
Spring Valley, California, United States
Unknown Facility
Wildomar, California, United States
Unknown Facility
Boulder, Colorado, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Winter Park, Florida, United States
Unknown Facility
Libertyville, Illinois, United States
Unknown Facility
Northbrook, Illinois, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Bardstown, Kentucky, United States
Unknown Facility
Owensboro, Kentucky, United States
Unknown Facility
Cambridge, Massachusetts, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Toms River, New Jersey, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Salem, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Jackson, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Lubbock, Texas, 79423, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Related Publications (1)
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.
PMID: 21494336RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amaury Sanchez, Sr. Manager, Regulatory Affairs
- Organization
- Noven Pharmaceuticals, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Wilens, MD
Harvard Medical School (HMS and HSDM)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2007
First Posted
February 13, 2007
Study Start
January 1, 2007
Primary Completion
August 1, 2007
Study Completion
July 1, 2008
Last Updated
April 26, 2017
Results First Posted
March 6, 2009
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share