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

NCT ID: NCT00857220

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-10-31

Brief 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

Keywords

Hypnotic; Eszopiclone; Attention Deficit Hyperactivity Disorder; Insomnia; Children; Adolescent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2mg eszopiclone (6-11yrs), 3mg eszopiclone (12-17yrs)

Group Type: EXPERIMENTAL

eszopiclone

Intervention Type: DRUG

One 2 mg tablet per day for 12 months

eszopiclone

Intervention Type: DRUG

one 3mg tablet per day for 12 months

Interventions

eszopiclone

One 2 mg tablet per day for 12 months

Intervention Type: DRUG

eszopiclone

one 3mg tablet per day for 12 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject is male or female 6 17 years of age, inclusive, at the time of consent.
• Subject must have a diagnosis of ADHD as defined by DSM-IV criteria • The diagnosis for Rollover subjects will be taken from the Screening visit of Study 190 246. Treatment naïve subjects will have these assessments performed at the Screening visit.
• 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 has either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake time after sleep onset (WASO) demonstrated by PSG.
• 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 at screening
• Subject must be in good general health.
• Subject must be able to swallow tablets.
• If subjects are currently taking medication for ADHD, they must be on a stable dose and regimen for at least one month, and preferably for at least 3 months 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 abnormality/illness
• Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder (other than obsessive-compulsive disorder) or any history of psychosis, as determined by medical or psychiatric history or as determined by clinical interview using the MINI-Kid at Visit 1.
• Subject has periodic limb movement >5 times per hour, as demonstrated on PSG.
• Subject has sleep disordered breathing, as demonstrated on PSG.
• Subject has another primary sleep disorder (or secondary sleep disorder that is causing clinical impairment 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, lactating or planning to become pregnant.
• Subject is taking any psychotropic or disallowed medications,
• 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
• Subject has participated in any investigational study within 30 days prior to study entry or is currently participating in another clinical trial, except Study 190 246.

• 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

REM Medical Clinical Research

Tucson, Arizona, United States

Clinical Study Centers, LLC

Little Rock, Arkansas, United States

AV Institute, Inc.

Carson, California, United States

Clinical Innovations, Inc.

Costa Mesa, California, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Sun Valley Research Center

Imperial, 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, Inc.

Orange, California, United States

Clinical Innovations, Inc.

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Clinical Innovations

San Diego, California, United States

Neuropsychiatric Research Center of Orange County

Santa Ana, California, United States

Apex Research Institute

Santa Ana, California, United States

Clinical Innovations, Inc.

Santa Ana, California, United States

Elite Clinical Trials, Inc.

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

Amedica Research Institute, Inc.

Hialeah, Florida, United States

Behavioral Clinical Research Inc.

Lauderhill, Florida, United States

Behavioral Clinical Research, Inc.

Lauderhill, Florida, United States

Pediatric Neurology and Epilepsy Center

Loxahatchee Groves, Florida, United States

Florida Clinical Research Center, LLC

Maitland, Florida, United States

Scientific Clinical Research Inc.

North Miami, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

Florida Institute for Clinical Research, LLC

Orlando, Florida, United States

DMI Research Inc.

Pinellas Park, Florida, United States

Florida Sleep Institute

Spring Hill, Florida, United States

SomnoMedics, LLC

Tampa, Florida, United States

Sleep Disorders Center of Georgia

Atlanta, Georgia, United States

Northwest Behavioral Research Center

Roswell, Georgia, United States

Mountain West Clinical Trials

Eagle, Idaho, United States

Suburban Lung Associates, SC

Elk Grove Village, Illinois, United States

Capstone Clinical Research

Libertyville, Illinois, United States

AMR Baber Research, Inc.

Naperville, Illinois, United States

Sleep and Behavior Medicine Institute

Vernon Hills, Illinois, United States

Davis Clinic

Indianapolis, Indiana, United States

Goldpoint Clinical Research, LLC

Indianapolis, Indiana, United States

Nassim, McMonigle, Mescia & Associates

New Albany, Indiana, United States

Psychiatric Associates

Overland Park, Kansas, United States

Brownsboro Park Pediatrics

Louisville, Kentucky, United States

Pedia Research, LLC

Owensboro, Kentucky, United States

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Louisiana Research Associates, Inc.

New Orleans, Louisiana, United States

MD

Chevy Chase, Maryland, United States

ActivMed Practices and Research

Haverhill, Massachusetts, United States

Neurocare, Inc.

Newton, Massachusetts, United States

ActivMed Practices and Research

North Andover, Massachusetts, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Clinical Nuerophysiology Services, PC

Sterling Heights, Michigan, United States

Precise Research Centers

Flowood, Mississippi, United States

Premier Psychicatric Research Institute, LLC

Lincoln, Nebraska, United States

Midwest Children's Health Research Institute

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

Global Medical Institutes, LLC

Princeton, New Jersey, United States

CRI Worldwide, LLC

Willingboro, New Jersey, United States

NorthCoast Clinical Trials, Inc.

Beachwood, Ohio, United States

Neuro-Behavioral Clnical Research

Canton, Ohio, United States

Cleveland Sleep Research Center

Middleburg Heights, Ohio, United States

North Star Medical Research, LLC

Middleburg Heights, Ohio, United States

Cutting Edge Research of Enid

Enid, Oklahoma, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Pahl Pharmaceutical Professionals, LLC

Oklahoma City, Oklahoma, United States

SP Research

Oklahoma City, Oklahoma, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Eminence Research LLC

Oklahoma City, Oklahoma, United States

Paradigm Research Professonals, LLP

Tulsa, Oklahoma, United States

Tulsa Clinical Research

Tulsa, Oklahoma, United States

Cyn3rgy Research

Gresham, Oregon, United States

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, United States

Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)

Salem, Oregon, United States

CRI Worldwide

Philadelphia, Pennsylvania, United States

Omega Medical Research

Warwick, Rhode Island, United States

Holston Medical Group

Kingsport, Tennessee, United States

Academy of Clinical Research

Arlington, Texas, United States

Pillar Clinical Research, LLC

Dallas, Texas, United States

InSite Clinical Research

DeSoto, Texas, United States

Claghorn-Lesem Research Clinic, Ltd.

Houston, Texas, United States

Allegiant Clinical Research

Houston, Texas, United States

MD

Houston, Texas, United States

The Mech Center

Plano, Texas, United States

Road Runner Research

San Antonio, Texas, United States

Aspen Clinical Research, LLC

Orem, Utah, United States

Alliance Research Group

Richmond, Virginia, United States

Brighton Research Group, LLC

Virginia Beach, Virginia, 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

190-247

Identifier Type: -

Identifier Source: org_study_id