Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Novartis90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

ADHD

Interventions

Focalin XRDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Bayou City Research

Houston, Texas, United States

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.

Data from ClinicalTrials.gov

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