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

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Trial Summary
Trial Overview
Inclusion Criteria

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
SDS Clinical Trials
Orange, California 92868
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Clinical Insights
7310 Ritchie Highway Glen Burnie
5, Maryland 21061
410-768-2629
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5, MD
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Sleep Disorders Center of Alabama
790 Montclair Road
Birmingham, Alabama 35213
205-599-1020
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Birmingham, AL
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Northwest Clinical Research Center
1952 - 152nd Place NE
East Seattle, Washington 98007
425-453-0404
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East Seattle, WA
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MD Clinical
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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CRI Worldwide
16000 Horizon Way Mount
Mt Laurel, New Jersey 08054
856-533-5020
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OmniTrials
11181 Health Park Blvd
Naples, Florida 34110
239-566-1192
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Naples, FL
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InSite Clinical Research
941 York Drive DeSoto
Southwest, Texas 75115
214-477-5162
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Southwest, TX
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Sleep Disorders Center of Georgia
Atlanta, Georgia 30342
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Atlanta, GA
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NeuroTrials Research, Incorporated
Atlanta, Georgia 30342
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Atlanta, GA
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Gulf Coast Research
Baton Rouge, Louisiana 70808
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Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302
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AV Institute, Inc.
Carson, California 90746
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Carson, CA
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Metropolitan Neuro Behavioral Institute
Chandler, Arizona 85226
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Carolina Clinical Trials, Inc.
Charleston, South Carolina 29405
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Chicago Research Center, Inc
Chicago, Illinois 60634
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Chicago, IL
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Tristate Sleep Disorders Center
Cincinnati, Ohio 45246
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Introspect of Buxmont
Colmar, Pennsylvania 18915
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Delta Waves, INC
Colorado Springs, Colorado 80918
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Dothan Behavioral Medicine Clinic
Dothan, Alabama 36303
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Mountain West Clinical Trials
Eagle, Idaho 83616
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Synergy Clinical Research
Escondido, California 92025
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Escondido, CA
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Synergy Clinical Research Center
Farmingdale, New York 11735
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Farmingdale, NY
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Avastra Clinical Trials
Fountain Valley, California 92708
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Fountain Valley, CA
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Sarkis Clinical Trials
Gainesville, Florida 32607
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MD & Associates, Inc.
Garfield Heights, Ohio 44125
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Garfield Heights, OH
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Behavioral Research Specialists, LLC
Glendale, California 91204
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Glendale, CA
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Mid-Michigan Sleep Center
Grand Blanc, Michigan 48439
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Grand Blanc, MI
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Cyn3rgy Research
Gresham, Oregon 97030
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Gresham, OR
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Clinical Research Center of Nevada
Henderson, Nevada 89015
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Henderson, NV
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Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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Claghorn-Lesem Research Clinic
Houston, Texas 77008
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Todd J. Swick, MD, PA
Houston, Texas 77063
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Allegiant Clinical Research, LLC
Houston, Texas 77024
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Clinical Trial Facility in Houston Texas
Houston, Texas 77042
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Davis Clinic
Indianapolis, Indiana 46260
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Indianapolis, IN
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Goldpoint Clinical Research
Indianapolis, Indiana 46260
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Indianapolis, IN
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Eastside Therapeutic Resource
Kirkland, Washington 98033
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Kirkland, WA
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Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada 89128
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Las Vegas, NV
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Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska 68510
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Lincoln, NE
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Paul E. Wylie
Little Rock, Arkansas 72211
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Little Rock, AR
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Pacific Institute for Medical Research Inc
Los Angeles, California 90024
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Florida Clinical Research Center LLC
Maitland, Florida 32751
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AMR Baber Research Inc.
Naperville, Illinois 60563
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Naperville, IL
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Louisiana Research Associates, Inc.
New Orleans, Louisiana 70114
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Pedia Research
Newburgh, Indiana 42301
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Newburgh, IN
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Neurocare, Inc.
Newton, Massachusetts 02459
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Newton, MA
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American Medical Research, Inc.
Oak Brook, Illinois 60523
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North County Clinical Research
Oceanside, California 92056
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Excell Research, Inc.
Oceanside, California 92056
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Eminence Research, LLC
Oklahoma City, Oklahoma 73139
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Pahl Pharmaceutical Professionals, LLC
Oklahoma City, Oklahoma 73112
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Cutting Edge Research
Oklahoma City, Oklahoma 73116
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IPS Research
Oklahoma City, Oklahoma 73103
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Pacific Clinical Research Medical Group
Orange, California 92868
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Saint Charles Hospital
2600 Navarre Ave
Oregon, Ohio 43616
(419) 696-7200
Saint Charles Hospital Since 1953, Mercy St. Charles Hospital has been providing for the healthcare...
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Aspen Clinical Research, LLC
Orem, Utah 84058
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Florida Institute for Clinical Research, LLC
Orlando, Florida 32822
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Vince and Associates Clinical Research
Overland Park, Kansas 23112
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Overland Park, KS
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Psychiatric Associates
Overland Park, Kansas 66211
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California Clinical Trials Medical Group
Paramount, California 90723
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Paramount, CA
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CRI Worldwide, LLC
Philadelphia, Pennsylvania 19139
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Philadelphia, PA
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PsyPharma Clinical Research
Phoenix, Arizona 85050
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The Mech Center
Plano, Texas 75024
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Oregon Center for Clinical Investigations, Inc.
Portland, Oregon 97210
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Portland, OR
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Artemis Institiute for Clinical Research
San Diego, California 92123
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Clinical Innovations, Inc.
Santa Ana, California 92705
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Santa Ana, CA
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Neuropsychiatric Research Center of Orange County
Santa Ana, California 92701
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Santa Ana, CA
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SomnoMedics, LLC
Tampa, Florida 33607
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Pediatric Epilepsy and Neurology Specialists
Tampa, Florida 33609
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Tampa, FL
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Clinical Neurophysiology Services, P.C.
Troy, Michigan 48085
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Troy, MI
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REM Medical Clinical Research
Tucson, Arizona 85712
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Tulsa Clinical Research
Tulsa, Oklahoma 74104
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Paradigm Research Professional, LLP
Tulsa, Oklahoma 74114
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Elite Clinical Trials
Wildomar, California 92595
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