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Completed

NCT Number: NCT00151970

Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed 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

About this study

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects have primary diagnosis of ADHD
  • Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
  • Subject has an IQ score of >_ 80
  • Subject is able to complete as least the Basic Test of the PERMP assessment

Exclusion criteria

  • Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
  • Subject is taking Strattera(r)
  • Subject has a recent history of suspected substance abuse or dependence disorder

Treatment and study plan

Methylphenidate Transdermal System

Drug

MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes

Other names: MTS

Placebo

Drug

Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily

Other names: Sham Treatment

Concerta

Drug

CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Other names: Methylphenidate HCL

Primary outcomes

  1. SKAMP deportment rating scale

    Time frame: Week 8

Secondary outcomes

  1. PERMP age-adjusted math test

    Time frame: Week 8

  2. Clinician-rated ADHD-RS-IV

    Time frame: Week 8

  3. CGI-I

    Time frame: Week 8

  4. Parent Global Assessment

    Time frame: Week 8

  5. Connors' Parent Rating Scale

    Time frame: Week 8

  6. ADHD Impact Module-Children

    Time frame: Week 8

  7. SKAMP-total and inattention subscales

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Noven Therapeutics

Industry

Collaborators

  • Noven Pharmaceuticals, Inc.

Registry information

Official study title

A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Jul 9, 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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