Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

March 27, 2017 updated by: Noven Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Irvine, California, United States
      • San Marcos, California, United States
      • Spring Valley, California, United States
      • Wildomar, California, United States
    • Colorado
      • Boulder, Colorado, United States
    • Florida
      • Gainesville, Florida, United States
      • Miami, Florida, United States
      • Winter Park, Florida, United States
    • Illinois
      • Libertyville, Illinois, United States
      • Northbrook, Illinois, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Kentucky
      • Bardstown, Kentucky, United States
      • Owensboro, Kentucky, United States
    • Massachusetts
      • Cambridge, Massachusetts, United States
    • Michigan
      • Kalamazoo, Michigan, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Tom's River, New Jersey, United States
    • New York
      • Rochester, New York, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
      • Salem, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Jackson, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Lubbock, Texas, United States, 79423
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylphenidate Transdermal System
To characterize the dermal reactions seen with the use of DAYTRANA
Drug: Daytrana
Methylphenidate Transdermal System (MTS)
Other Names:
  • MTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermal Reactions
Time Frame: 7 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contact Sensitization to Methylphenidate
Time Frame: 7 weeks
Contact sensitization to methylphenidate through skin patch testing.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noven Therapeutics

Investigators

  • Principal Investigator: Timothy Wilens, MD, Harvard Medical School (HMS and HSDM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD485-411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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