Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

ADHD Clinical Trial

Official title:

Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141050
• Other study ID #: CRIT124EUS12
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: December 17, 2007
• Start date: May 2005
• Est. completion date: July 2005

Study information

• Verified date: December 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• Focalin XR

Locations

Country	Name	City	State
United States	Bayou City Research	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in attention and deportment measured at 2 hours post-dose
Secondary	Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Secondary	Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Secondary	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.