NCT01101022

Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-controlled, Parallel Group Study Evaluating the Safety and Efficacy of SPD489 on Executive Function (Self-Regulation) Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Reporting Clinically Significant Impairment of Real-World Executive Function Behavior.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.

Conditions

• ADHD Specifically With Executive Function Impairment

Interventions

Type	Name	Description
DRUG	SPD489	1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks)
OTHER	Placebo	1 capsule per day, daily throughout the double-blind treatment period (10 weeks)

Timeline

• Start date: 2010-05-19
• Primary completion: 2010-11-29
• Completion: 2010-11-29
• First posted: 2010-04-09
• Last updated: 2021-06-09
• Results posted: 2012-02-13

Locations

39 sites across 1 country: United States