Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Novartis

Status and phase: Completed; Phase 3

Conditions: ADHD

Treatments: Drug: Focalin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141050

CRIT124EUS12

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind