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Completed

NCT Number: NCT00151983

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

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.

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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 3

Primary location

Meadowbrook Research, Inc., Scottsdale, Arizona, United States

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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 safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Methylphenidate Transdermal System

Drug

To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo

Other names: MTS

Primary outcomes

  1. Score on ADHD Rating Scale at 4 weeks

    Time frame: 30 days

Secondary outcomes

  1. Parent rating scale

    Time frame: 30 days

  2. Parent Global Assessment

    Time frame: 30 days

  3. Medication Satisfaction Survey

    Time frame: 30 days

  4. ADHD Impact Module

    Time frame: 30 days

  5. Clinical Global Impressions Scale

    Time frame: 30 days

  6. Adverse events, lab tests, dermal evaluations, ECGs

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Noven Therapeutics

Industry

Collaborators

  • Noven Pharmaceuticals, Inc.

Registry information

Official study title

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.

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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