Clinical trial NCT00856973: Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Attention Deficit Hyperactivity Disorder
Keywords: Hypnotic
Eszopiclone
Attention Deficit/Hyperactivity Disorder
Insomnia
Children
Adolescent
Polysomnography
Actigraphy
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 486
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).
timeFrame: Baseline (Day 0) to Week 12
Secondary outcomes:
measure: Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline in CGI-Child at Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in Subjective SL (Sleep Latency)
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.
timeFrame: Baseline (Day 0) to Week 11
measure: Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.
timeFrame: Baseline (Day 0) to Week 11
measure: Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.
timeFrame: Baseline (Day 0) to Week 11
measure: Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).
timeFrame: Baseline (Day 0) to Week 12
measure: Change in School Tardiness/Attendance Reports at Week 12 (Days)
timeFrame: Baseline (Day 0) to Week 12
measure: Change in School Tardiness/Attendance Reports at Week 12 (Hours)
timeFrame: Baseline (Day 0) to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Dothan
country: United States
facility: Dothan Behavioral Medicine Clinic
state: Alabama
city: Chandler
country: United States
facility: Metropolitan Neuro Behavioral Institute
state: Arizona
city: Phoenix
country: United States
facility: PsyPharma Clinical Research
state: Arizona
city: Tucson
country: United States
facility: REM Medical Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Paul E. Wylie
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: Fountain Valley
country: United States
facility: Avastra Clinical Trials
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Los Angeles
country: United States
facility: Pacific Institute for Medical Research Inc
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
state: California
city: Paramount
country: United States
facility: California Clinical Trials Medical Group
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, Inc.
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials
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: Maitland
country: United States
facility: Florida Clinical Research Center LLC
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: SomnoMedics, LLC
state: Florida
city: Tampa
country: United States
facility: Pediatric Epilepsy and Neurology Specialists
state: Florida
city: Atlanta
country: United States
facility: Neuro Trials Research, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Eagle
country: United States
facility: Mountain West Clinical Trials
state: Idaho
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Naperville
country: United States
facility: AMR Baber Research Inc.
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Davis Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research
state: Indiana
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Owensboro
country: United States
facility: Pedia Research LLC
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: Glen Burnie
country: United States
facility: Clinical Insights
state: Maryland
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group
state: Michigan
city: Grand Blanc
country: United States
facility: Mid-Michigan Sleep Center
state: Michigan
city: Troy
country: United States
facility: Clinical Neurophysiology Services, P.C.
state: Michigan
city: St. Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
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: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Farmingdale
country: United States
facility: Synergy Clinical Research Center
state: New York
city: Cincinnati
country: United States
facility: Tristate Sleep Disorders Center
state: Ohio
city: Garfield Heights
country: United States
facility: MD & Associates, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Reserach Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Professionals, LLC
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: Tulsa Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Paradigm Research Professional, LLP
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: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials Inc.
state: South Carolina
city: DeSoto
country: United States
facility: InSite Clinical Research LLC
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic
state: Texas
city: Houston
country: United States
facility: Allegiant Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: MD
state: Texas
city: Houston
country: United States
facility: Todd J. Swick, MD, PA
state: Texas
city: Lubbock
country: United States
facility: MD
state: Texas
city: Plano
country: United States
facility: The Mech Center
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research, LLC
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
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.