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
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, see Learn About Clinical Studies.

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:
Dexmethylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014