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

NCT ID: NCT00856973

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 486 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low dose eszopiclone

1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years

Group Type: EXPERIMENTAL

eszopiclone

Intervention Type: DRUG

1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years

High dose eszopiclone

2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years

Group Type: EXPERIMENTAL

eszopiclone

Intervention Type: DRUG

2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years

Placebo

Placebo 6-17 years

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 tablet per day for 12 weeks

Interventions

eszopiclone

1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years

Intervention Type: DRUG

eszopiclone

2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years

Intervention Type: DRUG

Placebo

1 tablet per day for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject is male or female 6 to 17 years of age, inclusive, at the time of consent.
• Subject must have a diagnosis of ADHD as defined by DSM-IV criteria
• Subject must have documented ADHD associated insomnia, defined as the subject or subject's parent/legal guardian having reported repeated difficulty with sleep initiation (sleep latency >30 minutes) or consolidation, (wake time after sleep onset >45 minutes) despite adequate age appropriate time and opportunity for sleep.
• Subject's Baseline PSG must reveal either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake after sleep onset (WASO).
• Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems.
• Subject or subject's parent/legal guardian should have reported attempted and failed behavioral interventions for sleep problems, including a regular bedtime and rise time
• Subject's sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication whether it is being used as intended or in an illicit manner.(Female subjects ≥8 years of age must have a negative serum pregnancy test)
• Subject must be in general good health
• Subject must be able to swallow tablets.
• If subject is currently taking medication for ADHD, they must be on a stable dose and regimen for a minimum of 1 month prior to the time of consent

Exclusion Criteria

• Subject with weight <10th percentile for age and gender
• Subject has any clinically significant or unstable medical illness/abnormality or chronic disease.
• Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder or any history of psychosis.
• Subject has periodic limb movement >5 times per hour, as demonstrated on Baseline PSG.
• Subject has sleep disordered breathing, as demonstrated on Baseline PSG.
• Subject has another primary sleep disorder, a secondary sleep disorder, or any other known or suspected medical or psychiatric condition that has affected or may affect sleep
• Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study.
• Subject has organic brain disease, or a history of febrile seizures.
• Subject is, in the opinion of the investigator, at suicidal or homicidal risk.
• Female subject who is pregnant or lactating or planning to become pregnant.
• Subject has taken any psychotropic medication without an appropriate washout period (≥5 half-lives) prior to randomization.
• Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
• Subject has a history of allergic reaction or has a known or suspected sensitivity to racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.
• Subject has a history of alcohol or substance abuse within 3 months of study participation.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Dothan Behavioral Medicine Clinic

Dothan, Alabama, United States

Metropolitan Neuro Behavioral Institute

Chandler, Arizona, United States

PsyPharma Clinical Research

Phoenix, Arizona, United States

REM Medical Clinical Research

Tucson, Arizona, United States

Paul E. Wylie

Little Rock, Arkansas, United States

AV Institute, Inc.

Carson, California, United States

Clinical Innovations, Inc.

Costa Mesa, California, United States

Avastra Clinical Trials

Fountain Valley, California, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Pacific Institute for Medical Research Inc

Los Angeles, California, United States

Excell Research, Inc.

Oceanside, California, United States

North County Clinical Research (NCCR)

Oceanside, California, United States

Pacific Clinical Research Medical Group

Orange, California, United States

SDS Clinical Trials

Orange, California, United States

California Clinical Trials Medical Group

Paramount, California, United States

Clinical Innovations, Inc.

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Clinical Innovations, Inc.

San Diego, California, United States

Neuropsychiatric Research Center of Orange County

Santa Ana, California, United States

Clinical Innovations, Inc.

Santa Ana, California, United States

Elite Clinical Trials

Wildomar, California, United States

Delta Waves, INC

Colorado Springs, Colorado, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

MD Clinical

Hallandale, Florida, United States

Florida Clinical Research Center LLC

Maitland, Florida, United States

Florida Institute for Clinical Research, LLC

Orlando, Florida, United States

SomnoMedics, LLC

Tampa, Florida, United States

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, United States

Neuro Trials Research, Inc.

Atlanta, Georgia, United States

Sleep Disorders Center of Georgia

Atlanta, Georgia, United States

Mountain West Clinical Trials

Eagle, Idaho, United States

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, United States

AMR Baber Research Inc.

Naperville, Illinois, United States

American Medical Research, Inc.

Oak Brook, Illinois, United States

Davis Clinic

Indianapolis, Indiana, United States

Goldpoint Clinical Research

Indianapolis, Indiana, United States

Psychiatric Associates

Overland Park, Kansas, United States

Pedia Research LLC

Owensboro, Kentucky, United States

Louisiana Research Associates, Inc.

New Orleans, Louisiana, United States

Clinical Insights

Glen Burnie, Maryland, United States

Neurocare, Inc.

Newton, Massachusetts, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Mid-Michigan Sleep Center

Grand Blanc, Michigan, United States

Clinical Neurophysiology Services, P.C.

Troy, Michigan, United States

Midwest Research Group

Saint Charles, Missouri, United States

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, United States

Clinical Research Center of Nevada

Henderson, Nevada, United States

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

CRI Worldwide, LLC

Willingboro, New Jersey, United States

Synergy Clinical Research Center

Farmingdale, New York, United States

Tristate Sleep Disorders Center

Cincinnati, Ohio, United States

MD & Associates, Inc.

Garfield Heights, Ohio, United States

IPS Reserach Company

Oklahoma City, Oklahoma, United States

Pahl Pharmaceutical Professionals, LLC

Oklahoma City, Oklahoma, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Eminence Research, LLC

Oklahoma City, Oklahoma, United States

Tulsa Clinical Research

Tulsa, Oklahoma, United States

Paradigm Research Professional, LLP

Tulsa, Oklahoma, United States

Cyn3rgy Research

Gresham, Oregon, United States

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, United States

CRI Worldwide

Philadelphia, Pennsylvania, United States

Carolina Clinical Trials Inc.

Charleston, South Carolina, United States

InSite Clinical Research LLC

DeSoto, Texas, United States

Claghorn-Lesem Research Clinic

Houston, Texas, United States

Allegiant Clinical Research, LLC

Houston, Texas, United States

MD

Houston, Texas, United States

Todd J. Swick, MD, PA

Houston, Texas, United States

MD

Lubbock, Texas, United States

The Mech Center

Plano, Texas, United States

Aspen Clinical Research, LLC

Orem, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Eastside Therapeutic Resource

Kirkland, Washington, United States

Countries

United States

References

Sangal RB, Blumer JL, Lankford DA, Grinnell TA, Huang H. Eszopiclone for insomnia associated with attention-deficit/hyperactivity disorder. Pediatrics. 2014 Oct;134(4):e1095-103. doi: 10.1542/peds.2013-4221.

Reference Type: DERIVED

PMID: 25266438 (View on PubMed)

Other Identifiers

190-246

Identifier Type: -

Identifier Source: org_study_id