Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy

July 8, 2015 updated by: Noven Therapeutics

A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.

This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 3

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
        • Meadowbrook Research, Inc.
    • California
      • San Marcos, California, United States
        • Psychiatric Centers at San Diego
    • Colorado
      • Boulder, Colorado, United States
        • Alpine Clinical Research Center
    • Florida
      • Miami, Florida, United States
        • Miami Research Associates, Inc.
    • Illinois
      • Libertyville, Illinois, United States
        • Capstone Clinical Research
    • Kentucky
      • Owensboro, Kentucky, United States
        • Pedia Research, LLC
    • Michigan
      • Kalamazoo, Michigan, United States
        • ProMed Pediatrics
    • New Jersey
      • Toms River, New Jersey, United States
        • Children's Specialized Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • North Carolina Neuropsychiatry PA
    • Ohio
      • Columbus, Ohio, United States
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • IPS Research Company
    • Oregon
      • Portland, Oregon, United States
        • Oregon Center for Clinical Investigations (OCCI, Inc.)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Cns Research Institute
      • Pittsburgh, Pennsylvania, United States
        • Western Psychiatric Institute & Clinic
    • Texas
      • Bellaire, Texas, United States
        • Claghorn-Lesem Research Clinic
      • San Antonio, Texas, United States
        • ADHD Clinic of San Antonio
    • Virginia
      • Herndon, Virginia, United States
        • Neuroscience, Inc.
      • Norfolk, Virginia, United States
        • Monarch Medical Research

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:

  • Subject must have a primary diagnosis of ADHD
  • Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day
  • Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test

Exclusion Criteria:

  • A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually
  • A recent history of suspected substance abuse or dependence disorder
  • Subject is taking Strattera
  • Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites

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
Active Comparator: Methylphenidate Transdermal System
Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
Drug: Methylphenidate Transdermal System
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Other Names:
  • MTS
Placebo Comparator: Placebo patch
Placebo patch applied daily for 8 weeks
Drug: Methylphenidate Transdermal System
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Other Names:
  • MTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on ADHD Rating Scale at 4 weeks
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Parent rating scale
Time Frame: 30 days
30 days
Parent Global Assessment
Time Frame: 30 days
30 days
Medication Satisfaction Survey
Time Frame: 30 days
30 days
ADHD Impact Module
Time Frame: 30 days
30 days
Clinical Global Impressions Scale
Time Frame: 30 days
30 days
Adverse events, lab tests, dermal evaluations, ECGs
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Noven Therapeutics

Collaborators

Noven Pharmaceuticals, Inc.

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

June 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD485-305

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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