Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
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
1 other identifier
interventional
486
1 country
73
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.
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
73 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
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
April 10, 2013
CompletedJune 17, 2013
May 1, 2013
2.2 years
March 4, 2009
November 2, 2012
June 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).
A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.
Baseline (Day 0) to Week 12
Secondary Outcomes (19)
Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)
Baseline (Day 0) to Week 12
Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12
Baseline (Day 0) to Week 12
Change From Baseline in CGI-Child at Week 12
Baseline (Day 0) to Week 12
Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.
Baseline (Day 0) to Week 12
Change From Baseline to Week 12 in Subjective SL (Sleep Latency)
Baseline (Day 0) to Week 12
- +14 more secondary outcomes
Study Arms (3)
Low dose eszopiclone
EXPERIMENTAL1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
High dose eszopiclone
EXPERIMENTAL2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Placebo
PLACEBO COMPARATORPlacebo 6-17 years
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213, United States
Dothan Behavioral Medicine Clinic
Dothan, Alabama, 36303, United States
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, 85226, United States
PsyPharma Clinical Research
Phoenix, Arizona, 85050, United States
REM Medical Clinical Research
Tucson, Arizona, 85712, United States
Paul E. Wylie
Little Rock, Arkansas, 72211, United States
AV Institute, Inc.
Carson, California, 90746, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92626, United States
Avastra Clinical Trials
Fountain Valley, California, 92708, United States
Behavioral Research Specialists, LLC
Glendale, California, 91204, United States
Pacific Institute for Medical Research Inc
Los Angeles, California, 90024, 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
Orange, California, 92868, United States
California Clinical Trials Medical Group
Paramount, California, 90723, United States
Clinical Innovations, Inc.
Riverside, California, 92506, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Clinical Innovations, Inc.
San Diego, California, 92128, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701, United States
Clinical Innovations, Inc.
Santa Ana, California, 92705, United States
Elite Clinical Trials
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, 33009, United States
Florida Clinical Research Center LLC
Maitland, Florida, 32751, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32822, United States
SomnoMedics, LLC
Tampa, Florida, 33607, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33609, United States
Neuro Trials Research, Inc.
Atlanta, Georgia, 30342, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342, United States
Mountain West Clinical Trials
Eagle, Idaho, 83616, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
AMR Baber Research Inc.
Naperville, Illinois, 60563, United States
American Medical Research, Inc.
Oak Brook, Illinois, 60523, United States
Davis Clinic
Indianapolis, Indiana, 46260, United States
Goldpoint Clinical Research
Indianapolis, Indiana, 46260, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Pedia Research LLC
Owensboro, Kentucky, 42301, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
Clinical Insights
Glen Burnie, Maryland, 21061, United States
Neurocare, Inc.
Newton, Massachusetts, 02459, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302, United States
Mid-Michigan Sleep Center
Grand Blanc, Michigan, 48439, United States
Clinical Neurophysiology Services, P.C.
Troy, Michigan, 48085, United States
Midwest Research Group
Saint Charles, Missouri, 63301, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68510, 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
CRI Worldwide, LLC
Willingboro, New Jersey, 08046, United States
Synergy Clinical Research Center
Farmingdale, New York, 11735, United States
Tristate Sleep Disorders Center
Cincinnati, Ohio, 45246, United States
MD & Associates, Inc.
Garfield Heights, Ohio, 44125, United States
IPS Reserach Company
Oklahoma City, Oklahoma, 73103, United States
Pahl Pharmaceutical Professionals, LLC
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
Tulsa Clinical Research
Tulsa, Oklahoma, 74104, United States
Paradigm Research Professional, LLP
Tulsa, Oklahoma, 74114, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210, United States
CRI Worldwide
Philadelphia, Pennsylvania, 19139, United States
Carolina Clinical Trials Inc.
Charleston, South Carolina, 29405, United States
InSite Clinical Research LLC
DeSoto, Texas, 75115, United States
Claghorn-Lesem Research Clinic
Houston, Texas, 77008, United States
Allegiant Clinical Research, LLC
Houston, Texas, 77024, United States
MD
Houston, Texas, 77042, United States
Todd J. Swick, MD, PA
Houston, Texas, 77063, United States
MD
Lubbock, Texas, 79423, United States
The Mech Center
Plano, Texas, 75024, United States
Aspen Clinical Research, LLC
Orem, Utah, 84058, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, 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
Per protocol, study did not have PSG adaptation nights at baseline and contained one PSG assessment post randomization visit
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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
July 1, 2011
Study Completion
July 1, 2011
Last Updated
June 17, 2013
Results First Posted
April 10, 2013
Record last verified: 2013-05