NCT00856973

Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

A Randomized, Placebo Controlled, Double Blind, Fixed Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

Detailed description

This is a multi center, randomized, double blind, placebo controlled, fixed dose study of eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17 years) or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

• Insomnia
• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	eszopiclone	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
DRUG	eszopiclone	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
DRUG	Placebo	1 tablet per day for 12 weeks

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-03-06
• Last updated: 2013-06-17
• Results posted: 2013-04-10

Locations

73 sites across 1 country: United States