Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Status: | Archived |
---|---|
Conditions: | Insomnia Sleep Studies, Neurology, Psychiatric |
Therapuetic Areas: | Neurology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | May 2009 |
End Date: | December 2011 |
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
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.
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.
We found this trial at
75
sites
1952 - 152nd Place NE
East Seattle, Washington 98007
East Seattle, Washington 98007
425-453-0404
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Saint Charles Hospital Since 1953, Mercy St. Charles Hospital has been providing for the healthcare...
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