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Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00141050
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : December 21, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
ADHD Drug: Focalin XR Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Study Start Date : May 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00141050     History of Changes
Other Study ID Numbers: CRIT124EUS12
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Novartis:
ADHD, children

Additional relevant MeSH terms:
Dexmethylphenidate Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents