Clinical trial NCT00857220: Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Attention Deficit Hyperactivity Disorder
Keywords: Hypnotic
Eszopiclone
Attention Deficit Hyperactivity Disorder
Insomnia
Children
Adolescent
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 304
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion 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.

Primary outcomes:
measure: Overall Incidence of Adverse Events
timeFrame: 12 Months (from the 1st dose to the end of study)
Secondary outcomes:
measure: Overall Incidence of Skin Reactions: Number of Events
timeFrame: 12 Months (from the 1st dose to the end of study)
measure: Overall Incidence of Skin Reactions: Number of Participant Affected
timeFrame: 12 Months (from the 1st dose to the end of study)
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses
timeFrame: 12 Months
measure: Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Change From Baseline at Month 12 in Subjective Sleep Latency (SL)
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Change From Baseline in Child Behavior Checklist (CBCL)
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Change From Baseline in Conners' Continuous Performance Test II (CCPT II)
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
measure: Change From Baseline in Pediatric Quality of Life Scale
timeFrame: Baseline and 12 Months (from the 1st dose to the end of study)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: REM Medical Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Carson
country: United States
facility: AV Institute, Inc.
state: California
city: Costa Mesa
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Oceanside
country: United States
facility: North County Clinical Research (NCCR)
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Orange
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: Riverside
country: United States
facility: Clinical Innovations, Inc.
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Clinical Innovations
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Colorado Springs
country: United States
facility: Delta Waves, Inc.
state: Colorado
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Institute, Inc.
state: Florida
city: Lauderhill
country: United States
facility: Behavioral Clinical Research Inc.
state: Florida
city: Lauderhill
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Loxahatchee Groves
country: United States
facility: Pediatric Neurology and Epilepsy Center
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research Inc.
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research, LLC
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research Inc.
state: Florida
city: Spring Hill
country: United States
facility: Florida Sleep Institute
state: Florida
city: Tampa
country: United States
facility: SomnoMedics, LLC
state: Florida
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Roswell
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Eagle
country: United States
facility: Mountain West Clinical Trials
state: Idaho
city: Elk Grove Village
country: United States
facility: Suburban Lung Associates, SC
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: AMR Baber Research, Inc.
state: Illinois
city: Vernon Hills
country: United States
facility: Sleep and Behavior Medicine Institute
state: Illinois
city: Indianapolis
country: United States
facility: Davis Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: New Albany
country: United States
facility: Nassim, McMonigle, Mescia & Associates
state: Indiana
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Louisville
country: United States
facility: Brownsboro Park Pediatrics
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: Chevy Chase
country: United States
facility: MD
state: Maryland
city: Haverhill
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: North Andover
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group
state: Michigan
city: Sterling Heights
country: United States
facility: Clinical Nuerophysiology Services, PC
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Lincoln
country: United States
facility: Premier Psychicatric Research Institute, LLC
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Henderson
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Princeton
country: United States
facility: Global Medical Institutes, LLC
state: New Jersey
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Beachwood
country: United States
facility: NorthCoast Clinical Trials, Inc.
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clnical Research
state: Ohio
city: Middleburg Heights
country: United States
facility: Cleveland Sleep Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Enid
country: United States
facility: Cutting Edge Research of Enid
state: Oklahoma
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Professionals, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: SP Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Oklahoma City
country: United States
facility: Eminence Research LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Paradigm Research Professonals, LLP
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Clinical Research
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
state: Oregon
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Arlington
country: United States
facility: Academy of Clinical Research
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Ltd.
state: Texas
city: Houston
country: United States
facility: Allegiant Clinical Research
state: Texas
city: Houston
country: United States
facility: MD
state: Texas
city: Plano
country: United States
facility: The Mech Center
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research, LLC
state: Utah
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Virginia Beach
country: United States
facility: Brighton Research Group, LLC
state: Virginia
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
Study officials:
References:
citation: 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.