Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00141050
First received: August 30, 2005
Last updated: December 17, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
ADHD
Drug: Focalin XR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in attention and deportment measured at 2 hours post-dose

Secondary Outcome Measures:
  • Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
  • Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
  • 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.

Estimated Enrollment: 90
Study Start Date: May 2005
Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to understand or follow instructions
  • Is pregnant
  • Diagnosis of tic disorder
  • History of seizure disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141050

Locations
United States, Texas
Bayou City Research
Houston, Texas, United States, 77007
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Matthew Brams, MD Bayou City Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141050     History of Changes
Other Study ID Numbers: CRIT124EUS12
Study First Received: August 30, 2005
Last Updated: December 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
ADHD, children

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014