Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD

June 23, 2015 updated by: Noven Therapeutics

A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2

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
    • California
      • Irvine, California, United States, 92612
        • UCI Child Development Center

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:

  • Primary diagnosis ADHD
  • Total score of greater than or equal to 26 on ADHD-RS-IV
  • IQ of greater than or equal to 80
  • Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline

Exclusion Criteria:

  • Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
  • Known nonresponder to psychostimulant treatment
  • BMI for age greater than 90th percentile
  • History of seizures during last 2 years
  • Conduct Disorder

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methylphenidate Transdermal System
Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks
Drug: Methylphenidate Transdermal System
Placebo
Other Names:
  • ADHD Patch
Placebo Comparator: Placebo
Transdermal patch, 0mg, daily for 11 weeks
Drug: Methylphenidate Transdermal System
Placebo
Other Names:
  • ADHD Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
Time Frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours
2,3,4.5,6,7.5,9,10.5 and 12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
PERMP scores
Time Frame: pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application
pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application
Clinician-rated ADHD-RS-IV score
Time Frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours
2,3,4.5,6,7.5,9,10.5 and 12 hours
CGI-I score
Time Frame: Weeks 1-9
Weeks 1-9
PGA
Time Frame: Weeks 1-9
Weeks 1-9
CPRS-R score
Time Frame: Weeks 1-9
Weeks 1-9

Collaborators and Investigators

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

Sponsor

Noven Therapeutics

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

Helpful Links

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

August 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 25, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD485-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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