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OpenTrials
Completed

NCT Number: NCT00141063

Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.

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Key information

Conditions

ADHD 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

Center for Psychiatry & Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DSM-IV diagnosis of ADHD
  • Males and females aged 6-12

Exclusion criteria

  • Inability of understand or follow instructions
  • Is pregnant
  • Diagnosis of tic disorder
  • History of seizure disorder

Treatment and study plan

Focalin XR

Drug

Primary outcomes

  1. Change in attention and deportment measured at 2 hours post-dose

Secondary outcomes

  1. Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose

  2. Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline

  3. Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Sep 1, 2005
Registry last updated
Dec 21, 2007

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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