Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: A 9-week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With Attention Deficit/Hyperactivity Disorder

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy and safety of modafinil administered once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with ADHD.

Clinical Trial Description

The primary objective of the study is to determine whether modafinil at 255, 340, 425, or 510 mg'day is more effective than a placebo in alleviating the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults as determined by the change from baseline in the total score from the investigator-completed Adult ADHD Investigator Symptoms Rating Scale (AISRS) the at endpoint (last post-baseline observation [week 9 or early termination]). ;

Study Design

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

Related Conditions & MeSH terms

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

• NCT number: NCT00315276
• Study type: Interventional
• Source: Teva Pharmaceutical Industries
• Status: Completed
• Phase: Phase 2
• Start date: May 2006
• Completion date: January 2007