Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
A Long Term, Open-Label, Safety Study of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
1 other identifier
interventional
304
1 country
89
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2009
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
July 22, 2013
CompletedOctober 26, 2017
September 1, 2017
2.4 years
March 4, 2009
November 2, 2012
September 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Incidence of Adverse Events
12 Months (from the 1st dose to the end of study)
Secondary Outcomes (13)
Overall Incidence of Skin Reactions: Number of Events
12 Months (from the 1st dose to the end of study)
Overall Incidence of Skin Reactions: Number of Participant Affected
12 Months (from the 1st dose to the end of study)
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses
12 Months
Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12
Baseline and 12 Months (from the 1st dose to the end of study)
Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12
Baseline and 12 Months (from the 1st dose to the end of study)
- +8 more secondary outcomes
Study Arms (1)
2mg eszopiclone (6-11yrs), 3mg eszopiclone (12-17yrs)
EXPERIMENTALInterventions
One 2 mg tablet per day for 12 months
Eligibility Criteria
You may qualify if:
- 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 naĂ¯ve 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
REM Medical Clinical Research
Tucson, Arizona, 85712, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
AV Institute, Inc.
Carson, California, 90746, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92626, United States
Behavioral Research Specialists, LLC
Glendale, California, 91204, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
North County Clinical Research (NCCR)
Oceanside, California, 92056, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
SDS Clinical Trials, Inc.
Orange, California, 92868, United States
Clinical Innovations, Inc.
Riverside, California, 92506, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Clinical Innovations
San Diego, California, 92128, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Clinical Innovations, Inc.
Santa Ana, California, 92705, United States
Elite Clinical Trials, Inc.
Wildomar, California, 92595, United States
Delta Waves, Inc.
Colorado Springs, Colorado, 80918, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
MD Clinical
Hallandale, Florida, 3309, United States
Amedica Research Institute, Inc.
Hialeah, Florida, 33013, United States
Behavioral Clinical Research Inc.
Lauderhill, Florida, 33319, United States
Behavioral Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Pediatric Neurology and Epilepsy Center
Loxahatchee Groves, Florida, 33470, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Scientific Clinical Research Inc.
North Miami, Florida, 33161, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32822, United States
DMI Research Inc.
Pinellas Park, Florida, 33782, United States
Florida Sleep Institute
Spring Hill, Florida, 34609, United States
SomnoMedics, LLC
Tampa, Florida, 33607, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342, United States
Northwest Behavioral Research Center
Roswell, Georgia, 30076, United States
Mountain West Clinical Trials
Eagle, Idaho, 83616, United States
Suburban Lung Associates, SC
Elk Grove Village, Illinois, 60007, United States
Capstone Clinical Research
Libertyville, Illinois, 601048, United States
AMR Baber Research, Inc.
Naperville, Illinois, 60563, United States
Sleep and Behavior Medicine Institute
Vernon Hills, Illinois, 60061, United States
Davis Clinic
Indianapolis, Indiana, 46260, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Nassim, McMonigle, Mescia & Associates
New Albany, Indiana, 47150, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Brownsboro Park Pediatrics
Louisville, Kentucky, 40207, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
MD
Chevy Chase, Maryland, 20815, United States
ActivMed Practices and Research
Haverhill, Massachusetts, 01830, United States
Neurocare, Inc.
Newton, Massachusetts, 02459, United States
ActivMed Practices and Research
North Andover, Massachusetts, 01845, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302, United States
Clinical Nuerophysiology Services, PC
Sterling Heights, Michigan, 48314, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Premier Psychicatric Research Institute, LLC
Lincoln, Nebraska, 68510, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68516, United States
Clinical Research Center of Nevada
Henderson, Nevada, 89015, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128, United States
Global Medical Institutes, LLC
Princeton, New Jersey, 08540, United States
CRI Worldwide, LLC
Willingboro, New Jersey, 08046, United States
NorthCoast Clinical Trials, Inc.
Beachwood, Ohio, 44122, United States
Neuro-Behavioral Clnical Research
Canton, Ohio, 44718, United States
Cleveland Sleep Research Center
Middleburg Heights, Ohio, 44130, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Cutting Edge Research of Enid
Enid, Oklahoma, 72703, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Pahl Pharmaceutical Professionals, LLC
Oklahoma City, Oklahoma, 73112, United States
SP Research
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Eminence Research LLC
Oklahoma City, Oklahoma, 73139, United States
Paradigm Research Professonals, LLP
Tulsa, Oklahoma, 74103, United States
Tulsa Clinical Research
Tulsa, Oklahoma, 74104, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, 97301, United States
CRI Worldwide
Philadelphia, Pennsylvania, 19139, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Academy of Clinical Research
Arlington, Texas, 76011, United States
Pillar Clinical Research, LLC
Dallas, Texas, 75243, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, 77008, United States
Allegiant Clinical Research
Houston, Texas, 77024, United States
MD
Houston, Texas, 77042, United States
The Mech Center
Plano, Texas, 75024, United States
Road Runner Research
San Antonio, Texas, 78258, United States
Aspen Clinical Research, LLC
Orem, Utah, 84058, United States
Alliance Research Group
Richmond, Virginia, 23230, United States
Brighton Research Group, LLC
Virginia Beach, Virginia, 23452, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
Related Publications (1)
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.
PMID: 25266438DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Designed to assess safety/tolerability. Efficacy endpoints evaluated w/ descriptive stats only, w/ no placebo group against which to assess the impact of therapy. \~40% completion rate typical for one year studies but limits interpretation of results.
Results Point of Contact
- Title
- CNS Medical Director
- Organization
- Sunovion
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2009
First Posted
March 6, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 26, 2017
Results First Posted
July 22, 2013
Record last verified: 2017-09