NCT00857220

Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia

A Long Term, Open-Label, Safety Study 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: 304 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

A multicenter study to evaluate the safety of eszopiclone 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, open label, long term safety study in pediatric subjects 6 through 17 years of age, inclusive, with a diagnosis of ADHD associated insomnia. Subjects who complete Study 190 246 (Rollover subjects) and meet the study enrollment criteria will be allowed to participate in this long term safety study. Additionally, Treatment naïve subjects will be enrolled in this long term safety study in order to meet the overall subject enrollment objective of obtaining 100 subjects with 12 months of treatment. 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	One 2 mg tablet per day for 12 months
DRUG	eszopiclone	one 3mg tablet per day for 12 months

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-03-06
• Last updated: 2017-10-26
• Results posted: 2013-07-22

Locations

89 sites across 1 country: United States