NCT01328756

Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks. A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population. In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404. Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine dimesylate	Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years

Timeline

• Start date: 2011-07-07
• Primary completion: 2014-09-30
• Completion: 2014-09-30
• First posted: 2011-04-05
• Last updated: 2021-06-10
• Results posted: 2015-08-06

Locations

35 sites across 10 countries: Belgium, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden, United Kingdom