Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Novartis1 site in 1 country90 target enrollmentJune 2005

ConditionsADHD

DrugsFocalin XR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: ADHD
Sponsor: Novartis
Enrollment: 90
Locations: 1
Primary Endpoint: Change in attention and deportment measured at 2 hours post-dose
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

August 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis

Eligibility 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

Outcomes

Primary Outcomes

Change in attention and deportment measured at 2 hours post-dose

Secondary Outcomes

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.