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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00856973

Public ClinicalTrials.gov record NCT00856973. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 4:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00856973
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
486 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2009
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011
Last update posted
Jun 16, 2013

2009 – 2011

United States locations

U.S. sites
73
U.S. states
29
U.S. cities
59
Facility City State ZIP Site status
Sleep Disorders Center of Alabama Birmingham Alabama 35213
Dothan Behavioral Medicine Clinic Dothan Alabama 36303
Metropolitan Neuro Behavioral Institute Chandler Arizona 85226
PsyPharma Clinical Research Phoenix Arizona 85050
REM Medical Clinical Research Tucson Arizona 85712
Paul E. Wylie Little Rock Arkansas 72211
AV Institute, Inc. Carson California 90746
Clinical Innovations, Inc. Costa Mesa California 92626
Avastra Clinical Trials Fountain Valley California 92708
Behavioral Research Specialists, LLC Glendale California 91204
Pacific Institute for Medical Research Inc Los Angeles California 90024
Excell Research, Inc. Oceanside California 92056
North County Clinical Research (NCCR) Oceanside California 92056
Pacific Clinical Research Medical Group Orange California 92868
SDS Clinical Trials Orange California 92868
California Clinical Trials Medical Group Paramount California 90723
Clinical Innovations, Inc. Riverside California 92506
Artemis Institute for Clinical Research San Diego California 92123
Clinical Innovations, Inc. San Diego California 92128
Neuropsychiatric Research Center of Orange County Santa Ana California 92701
Clinical Innovations, Inc. Santa Ana California 92705
Elite Clinical Trials Wildomar California 92595
Delta Waves, INC Colorado Springs Colorado 80918
Sarkis Clinical Trials Gainesville Florida 32607
MD Clinical Hallandale Florida 33009
Florida Clinical Research Center LLC Maitland Florida 32751
Florida Institute for Clinical Research, LLC Orlando Florida 32822
SomnoMedics, LLC Tampa Florida 33607
Pediatric Epilepsy and Neurology Specialists Tampa Florida 33609
Neuro Trials Research, Inc. Atlanta Georgia 30342
Sleep Disorders Center of Georgia Atlanta Georgia 30342
Mountain West Clinical Trials Eagle Idaho 83616
Alexian Brothers Center for Psychiatric Research Hoffman Estates Illinois 60169
AMR Baber Research Inc. Naperville Illinois 60563
American Medical Research, Inc. Oak Brook Illinois 60523
Davis Clinic Indianapolis Indiana 46260
Goldpoint Clinical Research Indianapolis Indiana 46260
Psychiatric Associates Overland Park Kansas 66211
Pedia Research LLC Owensboro Kentucky 42301
Louisiana Research Associates, Inc. New Orleans Louisiana 70114
Clinical Insights Glen Burnie Maryland 21061
Neurocare, Inc. Newton Massachusetts 02459
Neurobehavioral Medicine Group Bloomfield Hills Michigan 48302
Mid-Michigan Sleep Center Grand Blanc Michigan 48439
Clinical Neurophysiology Services, P.C. Troy Michigan 48085
Midwest Research Group Saint Charles Missouri 63301
Premier Psychiatric Research Institute, LLC Lincoln Nebraska 68510
Clinical Research Center of Nevada Henderson Nevada 89015
Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada 89128
CRI Worldwide, LLC Willingboro New Jersey 08046
Synergy Clinical Research Center Farmingdale New York 11735
Tristate Sleep Disorders Center Cincinnati Ohio 45246
MD & Associates, Inc. Garfield Heights Ohio 44125
IPS Reserach Company Oklahoma City Oklahoma 73103
Pahl Pharmaceutical Professionals, LLC Oklahoma City Oklahoma 73112
Cutting Edge Research Group Oklahoma City Oklahoma 73116
Eminence Research, LLC Oklahoma City Oklahoma 73139
Tulsa Clinical Research Tulsa Oklahoma 74104
Paradigm Research Professional, LLP Tulsa Oklahoma 74114
Cyn3rgy Research Gresham Oregon 97030
Oregon Center for Clinical Investigations, Inc. Portland Oregon 97210
CRI Worldwide Philadelphia Pennsylvania 19139
Carolina Clinical Trials Inc. Charleston South Carolina 29405
InSite Clinical Research LLC DeSoto Texas 75115
Claghorn-Lesem Research Clinic Houston Texas 77008
Allegiant Clinical Research, LLC Houston Texas 77024
MD Houston Texas 77042
Todd J. Swick, MD, PA Houston Texas 77063
MD Lubbock Texas 79423
The Mech Center Plano Texas 75024
Aspen Clinical Research, LLC Orem Utah 84058
Northwest Clinical Research Center Bellevue Washington 98007
Eastside Therapeutic Resource Kirkland Washington 98033

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00856973, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 16, 2013 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00856973 live on ClinicalTrials.gov.

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