Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00141050

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 III

Drug Information available for: Dexmethylphenidate Dexmethylphenidate hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

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

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

Keywords provided by Novartis:

ADHD, children

Study placed in the following topic categories:

Dopamine
Methylphenidate

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009