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Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141063
First Posted: September 1, 2005
Last Update Posted: December 21, 2007
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.
Information provided by:
Novartis
  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
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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: June 2005
Study Completion Date: August 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 of 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): NCT00141063


Locations
United States, Nevada
Center for Psychiatry & Behavioral Medicine
Las Vegas, Nevada, United States, 89128
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Ann Childress, MD Center for Psychiatry and Behavioral Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00141063     History of Changes
Other Study ID Numbers: CRIT124EUS13
First Submitted: August 30, 2005
First Posted: September 1, 2005
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