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Completed

NCT Number: NCT00466791

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

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

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCI Child Development Center

Irvine, California, 92612, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate Transdermal System

Drug

Placebo

Other names: ADHD Patch

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Clinician-rated ADHD-RS-IV score

    Time frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours

  3. CGI-I score

    Time frame: Weeks 1-9

  4. PGA

    Time frame: Weeks 1-9

  5. CPRS-R score

    Time frame: Weeks 1-9

Sponsors and collaborators

Lead sponsor

Noven Therapeutics

Industry

Registry information

Official study title

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)

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 27, 2007
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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