Back to resultsSafety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Primary Purpose
Insomnia, Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
eszopiclone
eszopiclone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Hypnotic, Eszopiclone, Attention Deficit/Hyperactivity Disorder, Insomnia, Children, Adolescent, Polysomnography, Actigraphy
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.
Sites / Locations
- Sleep Disorders Center of Alabama
- Dothan Behavioral Medicine Clinic
- Metropolitan Neuro Behavioral Institute
- PsyPharma Clinical Research
- REM Medical Clinical Research
- Paul E. Wylie
- AV Institute, Inc.
- Clinical Innovations, Inc.
- Avastra Clinical Trials
- Behavioral Research Specialists, LLC
- Pacific Institute for Medical Research Inc
- Excell Research, Inc.
- North County Clinical Research (NCCR)
- Pacific Clinical Research Medical Group
- SDS Clinical Trials
- California Clinical Trials Medical Group
- Clinical Innovations, Inc.
- Artemis Institute for Clinical Research
- Clinical Innovations, Inc.
- Neuropsychiatric Research Center of Orange County
- Clinical Innovations, Inc.
- Elite Clinical Trials
- Delta Waves, INC
- Sarkis Clinical Trials
- MD Clinical
- Florida Clinical Research Center LLC
- Florida Institute for Clinical Research, LLC
- SomnoMedics, LLC
- Pediatric Epilepsy and Neurology Specialists
- Neuro Trials Research, Inc.
- Sleep Disorders Center of Georgia
- Mountain West Clinical Trials
- Alexian Brothers Center for Psychiatric Research
- AMR Baber Research Inc.
- American Medical Research, Inc.
- Davis Clinic
- Goldpoint Clinical Research
- Psychiatric Associates
- Pedia Research LLC
- Louisiana Research Associates, Inc.
- Clinical Insights
- Neurocare, Inc.
- Neurobehavioral Medicine Group
- Mid-Michigan Sleep Center
- Clinical Neurophysiology Services, P.C.
- Midwest Research Group
- Premier Psychiatric Research Institute, LLC
- Clinical Research Center of Nevada
- Center for Psychiatry and Behavioral Medicine, Inc.
- CRI Worldwide, LLC
- Synergy Clinical Research Center
- Tristate Sleep Disorders Center
- MD & Associates, Inc.
- IPS Reserach Company
- Pahl Pharmaceutical Professionals, LLC
- Cutting Edge Research Group
- Eminence Research, LLC
- Tulsa Clinical Research
- Paradigm Research Professional, LLP
- Cyn3rgy Research
- Oregon Center for Clinical Investigations, Inc.
- CRI Worldwide
- Carolina Clinical Trials Inc.
- InSite Clinical Research LLC
- Claghorn-Lesem Research Clinic
- Allegiant Clinical Research, LLC
- MD
- Todd J. Swick, MD, PA
- MD
- The Mech Center
- Aspen Clinical Research, LLC
- Northwest Clinical Research Center
- Eastside Therapeutic Resource
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Low dose eszopiclone
High dose eszopiclone
Placebo
Arm Description
1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Placebo 6-17 years
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)
A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) 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 WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.
Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12
The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject's parent or caregiver and represented their assessment of severity and improvement in the subject's symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).
Change From Baseline in CGI-Child at Week 12
The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject's assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).
Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.
The Conners' 3 -Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners' 3 -Parent Short Form was a subset of items from the full-length form, and included the Conners' 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].
Change From Baseline to Week 12 in Subjective SL (Sleep Latency)
A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.
Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).
A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.
Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)
A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.
Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).
A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject's sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.
Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)
A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.
Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).
A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.
Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.
A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.
A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.
A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.
The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.
Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.
These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.
Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).
The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.
Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).
A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.
Change in School Tardiness/Attendance Reports at Week 12 (Days)
School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.
Change in School Tardiness/Attendance Reports at Week 12 (Hours)
School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.
Full Information
NCT ID
NCT00856973
First Posted
March 4, 2009
Last Updated
June 7, 2013
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00856973
Brief Title
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
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Attention Deficit Hyperactivity Disorder
Keywords
Hypnotic, Eszopiclone, Attention Deficit/Hyperactivity Disorder, Insomnia, Children, Adolescent, Polysomnography, Actigraphy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
486 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose eszopiclone
Arm Type
Experimental
Arm Description
1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
Arm Title
High dose eszopiclone
Arm Type
Experimental
Arm Description
2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 6-17 years
Intervention Type
Drug
Intervention Name(s)
eszopiclone
Intervention Description
1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
Intervention Type
Drug
Intervention Name(s)
eszopiclone
Intervention Description
2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet per day for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).
Description
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.
Time Frame
Baseline (Day 0) to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)
Description
A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) 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 WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12
Description
The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject's parent or caregiver and represented their assessment of severity and improvement in the subject's symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline in CGI-Child at Week 12
Description
The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject's assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.
Description
The Conners' 3 -Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners' 3 -Parent Short Form was a subset of items from the full-length form, and included the Conners' 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in Subjective SL (Sleep Latency)
Description
A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).
Description
A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)
Description
A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).
Description
A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject's sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)
Description
A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).
Description
A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.
Description
A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Time Frame
Baseline (Day 0) to Week 11
Title
Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.
Description
A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Time Frame
Baseline (Day 0) to Week 11
Title
Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.
Description
A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Time Frame
Baseline (Day 0) to Week 11
Title
Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.
Description
The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.
Description
These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).
Description
The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).
Description
A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.
Time Frame
Baseline (Day 0) to Week 12
Title
Change in School Tardiness/Attendance Reports at Week 12 (Days)
Description
School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.
Time Frame
Baseline (Day 0) to Week 12
Title
Change in School Tardiness/Attendance Reports at Week 12 (Hours)
Description
School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.
Time Frame
Baseline (Day 0) to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Dothan Behavioral Medicine Clinic
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Metropolitan Neuro Behavioral Institute
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
Facility Name
PsyPharma Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
REM Medical Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Paul E. Wylie
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
AV Institute, Inc.
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Avastra Clinical Trials
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Pacific Institute for Medical Research Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Excell Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
North County Clinical Research (NCCR)
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
SDS Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Clinical Trials Medical Group
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Innovations, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Elite Clinical Trials
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Delta Waves, INC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Florida Clinical Research Center LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Florida Institute for Clinical Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
SomnoMedics, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Pediatric Epilepsy and Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Neuro Trials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Sleep Disorders Center of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Mountain West Clinical Trials
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
AMR Baber Research Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
American Medical Research, Inc.
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Davis Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Goldpoint Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pedia Research LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Louisiana Research Associates, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Clinical Insights
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Neurocare, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Neurobehavioral Medicine Group
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Mid-Michigan Sleep Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Clinical Neurophysiology Services, P.C.
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Midwest Research Group
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Premier Psychiatric Research Institute, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89015
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
CRI Worldwide, LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Synergy Clinical Research Center
City
Farmingdale
State/Province
New York
ZIP/Postal Code
11735
Country
United States
Facility Name
Tristate Sleep Disorders Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
MD & Associates, Inc.
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
IPS Reserach Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Pahl Pharmaceutical Professionals, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Eminence Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73139
Country
United States
Facility Name
Tulsa Clinical Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Paradigm Research Professional, LLP
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
CRI Worldwide
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Carolina Clinical Trials Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
InSite Clinical Research LLC
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Claghorn-Lesem Research Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Allegiant Clinical Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
Facility Name
Todd J. Swick, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
MD
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
Facility Name
The Mech Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Aspen Clinical Research, LLC
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25266438
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.
Results Reference
derived
Learn more about this trial
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
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