Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: A 6-week, Double-Blind, Placebo-Controlled, Parallel Group Randomized Withdrawal Study to Evaluate the Continued Efficacy of Modafinil Treatment in Dosages up to 425mg/Day in Patients With Attention-Deficit/Hyperactivity Disorder Who Are Responders to Modafinil Treatment, Followed by a 12-Month Open-Label Extension Period

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the continued efficacy of modafinil treatment, compared to placebo treatment, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.

Clinical Trial Description

The primary objective of the study is to evaluate the continued efficacy of modafinil treatment, compared to placebo treatment, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment, as assessed by the change from baseline (in this current study) in the total score from the ADHD Rating Scale, Fourth Edition (ADHD-RS-IV) (Home Version) at endpoint (week 6 or last double-blind post-baseline visit). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

• NCT number: NCT00343811
• Study type: Interventional
• Source: Teva Pharmaceutical Industries
• Status: Completed
• Phase: Phase 3
• Start date: June 2006
• Completion date: September 2006