Attention Deficit Hyperactivity Disorder, Insomnia
Conditions
Keywords
Hypnotic, Eszopiclone, Attention Deficit Hyperactivity Disorder, Insomnia, Children, Adolescent
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.
Interventions
DRUGeszopiclone
One 2 mg tablet per day for 12 months
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Incidence of Adverse Events | 12 Months (from the 1st dose to the end of study) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The C-SSRS is a physician-completed scale to assess any suicidal ideation and suicidal behavior. The C-SSRS contained questions about suicidal behavior and suicidal ideation. Subjects were placed into categories for suicidal behavior and for suicidal ideation based on their responses to various questions. Any suicidality was defined as suicidal behavior or suicidal ideation. The suicidal behavior categories were determined based on the response to the questions under suicidal behavior (Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior).The suicidal ideation categories were determined by examining the response to 5 questions under suicidal ideation (Wish to be Dead, Nonspecific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent). |
| 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) | 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 to 7 years of age, the Coding Copy Subtest B was used for subjects 8 to 16 years of age, and the DSST was used for subjects 17 years of age. The DSST consists of rows containing small blank squares, each paired with a randomly assigned numbers 1-9. Above the rows is a key that pairs each number with a symbol. The subject must fill in the blank spaces with the matching symbol that is in the key. For the Subcopy tests the subject simply copies the symbol above each empty square. 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. |
| 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) | 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 at Month 12 in Subjective Sleep Latency (SL) | Baseline and 12 Months (from the 1st dose to the end of study) | Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off. |
| Change From Baseline in Child Behavior Checklist (CBCL) | Baseline and 12 Months (from the 1st dose to the end of study) | CBCL was completed by parents or guardians who saw the child in home-like settings. It includes several competence items, open-ended items for describing the child's illnesses, disabilities, concerns about the child, best things about the child, and several items to rate behavioral, emotional, and social problems. Responses are recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The checklist contains 120 questions. The standardized score is computed by determining the z-score by subtracting the mean for the subject's age group and gender from the raw score and then dividing this by the standard deviation for the subject's age group and gender. Next, multiply the zscore by 15 and then add 100. For activities scale, social scale, school scale, and total competence scale, higher values indicate higher competencies. For Internalizing problems, externalizing problems, and total problems, higher values indicate more problems. |
| Overall Incidence of Skin Reactions: Number of Events | 12 Months (from the 1st dose to the end of study) | — |
| Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Baseline and 12 Months (from the 1st dose to the end of study) | The CCPT-II is a computer-based 14-minute, visual-performance task. During an administration, respondents were required to press the space bar or click the mouse whenever any letter except the target letter appears on the screen. The speed at which the letters were presented varied during the administration. There were 6 blocks, with 3 sub-blocks, each containing 20 trials (letter presentations). The interstimulus intervals (ISIs) were 1, 2, and 4 seconds with a display time of 250 milliseconds. The order in which the different ISIs were presented varied between blocks. Conners' CCPT-II provides the following measures:% Omissions,% Commissions, Hit Reaction Time, Hit Reaction Time Standard Error,Variability of Standard Error, Detectability (d'), Response Style (beta), Perseverations, Hit Reaction Time Block Change (Vigilance Measure), Hit Standard Error Block Change (Vigilance Measure), Hit Reaction Time ISI change, and Hit Standard Error ISI Change, Confidence Index. |
| Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO) | Baseline and 12 Months (from the 1st dose to the end of study) | The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, 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 the subject's sleep over a predefined time period. WASO was assessed based on the responses to the sleep questionnaire. |
| Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO) | Baseline and 12 Months (from the 1st dose to the end of study) | The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, 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 the subject's sleep over a predefined time period. NAASO was assessed based on the responses to the sleep questionnaire. |
| Change From Baseline at Month 12 in Subjective Total Sleep Time (TST). | Baseline and 12 Months (from the 1st dose to the end of study) | The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, 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 the subject's sleep over a predefined time period. TST was assessed based on the responses to the sleep questionnaire. |
| Change From Baseline in Pediatric Quality of Life Scale | Baseline and 12 Months (from the 1st dose to the end of study) | 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. The Physical Summary Score is computed by summing values for questions 1, 2a, 2b, 3 and 5 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. The Psychosocial Summary Score is computed by summing questions 4, 6, 7, 8, and 9 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. |
| Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12 | Baseline and 12 Months (from the 1st dose to the end of study) | The PDSS total score ranges from a low of 0 where the individual is endorsing each item at the lowest level of daytime sleepiness to a high of 32 where the individual is endorsing each item at the highest level of daytime sleepiness. |
Countries
United States
Participant flow
Pre-assignment details
The participant flow section includes all subjects randomized. The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. One subject did not receive study medication.
Participants by arm
| Arm | Count |
|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) Eszopiclone Overall | 303 |
| Total | 303 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 35 |
| Overall Study | Clinical Hold | 6 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 11 |
| Overall Study | Lost to Follow-up | 30 |
| Overall Study | Miscellaneous | 8 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Protocol Violation | 16 |
| Overall Study | Site Closed | 5 |
| Overall Study | Withdrawal by Subject | 67 |
Baseline characteristics
| Characteristic | 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) |
|---|---|
| Age, Categorical <=18 years | 303 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 11.2 years STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 303 participants |
| Sex: Female, Male Female | 119 Participants |
| Sex: Female, Male Male | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 179 / 303 |
| serious Total, serious adverse events | 4 / 303 |
Outcome results
Primary
Overall Incidence of Adverse Events
Time frame: 12 Months (from the 1st dose to the end of study)
Population: The intent-to-treat (ITT) population consisted of all enrolled subjects who had taken any study medication. One subject did not receive study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Overall Incidence of Adverse Events | Subjects with at least 1 TEAE | 212 participants |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Overall Incidence of Adverse Events | Potentially-related TEAE | 138 participants |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Overall Incidence of Adverse Events | Severe TEAE | 10 participants |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Overall Incidence of Adverse Events | Serious TEAE | 4 participants |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Overall Incidence of Adverse Events | Fatal TEAE | 1 participants |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Overall Incidence of Adverse Events | Discontinued study due to TEAE | 34 participants |
Secondary
Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)
The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, 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 the subject's sleep over a predefined time period. NAASO was assessed based on the responses to the sleep questionnaire.
Time frame: Baseline and 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO) | -0.8 Number of Awakenings | Standard Deviation 1.6 |
Secondary
Change From Baseline at Month 12 in Subjective Sleep Latency (SL)
Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off.
Time frame: Baseline and 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline at Month 12 in Subjective Sleep Latency (SL) | -18.1 Minutes | Standard Deviation 87.3 |
Secondary
Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).
The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, 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 the subject's sleep over a predefined time period. TST was assessed based on the responses to the sleep questionnaire.
Time frame: Baseline and 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline at Month 12 in Subjective Total Sleep Time (TST). | 45.3 Minutes | Standard Deviation 119.8 |
Secondary
Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)
The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, 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 the subject's sleep over a predefined time period. WASO was assessed based on the responses to the sleep questionnaire.
Time frame: Baseline and 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO) | -22.7 Minutes | Standard Deviation 70.5 |
Secondary
Change From Baseline in Child Behavior Checklist (CBCL)
CBCL was completed by parents or guardians who saw the child in home-like settings. It includes several competence items, open-ended items for describing the child's illnesses, disabilities, concerns about the child, best things about the child, and several items to rate behavioral, emotional, and social problems. Responses are recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The checklist contains 120 questions. The standardized score is computed by determining the z-score by subtracting the mean for the subject's age group and gender from the raw score and then dividing this by the standard deviation for the subject's age group and gender. Next, multiply the zscore by 15 and then add 100. For activities scale, social scale, school scale, and total competence scale, higher values indicate higher competencies. For Internalizing problems, externalizing problems, and total problems, higher values indicate more problems.
Time frame: Baseline and 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Child Behavior Checklist (CBCL) | Activities scale standardized score | 1.04 units on a scale | Standard Deviation 13.83 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Child Behavior Checklist (CBCL) | Social scale standardized score | 0.94 units on a scale | Standard Deviation 14.29 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Child Behavior Checklist (CBCL) | School scale standardized score | 0.02 units on a scale | Standard Deviation 11.49 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Child Behavior Checklist (CBCL) | Total competence standardized score | 1.02 units on a scale | Standard Deviation 13.34 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Child Behavior Checklist (CBCL) | Externalizing problems standardized score | 0.29 units on a scale | Standard Deviation 12.33 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Child Behavior Checklist (CBCL) | Total problems standardized score | 0.19 units on a scale | Standard Deviation 14.16 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Child Behavior Checklist (CBCL) | Internalizing problems standardized score | 0.19 units on a scale | Standard Deviation 15.13 |
Secondary
Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12
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 to 7 years of age, the Coding Copy Subtest B was used for subjects 8 to 16 years of age, and the DSST was used for subjects 17 years of age. The DSST consists of rows containing small blank squares, each paired with a randomly assigned numbers 1-9. Above the rows is a key that pairs each number with a symbol. The subject must fill in the blank spaces with the matching symbol that is in the key. For the Subcopy tests the subject simply copies the symbol above each empty square. 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 and 12 Months (from the 1st dose to the end of study)
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12 | 1.1 score | Standard Deviation 6.1 |
Secondary
Change From Baseline in Conners' Continuous Performance Test II (CCPT II)
The CCPT-II is a computer-based 14-minute, visual-performance task. During an administration, respondents were required to press the space bar or click the mouse whenever any letter except the target letter appears on the screen. The speed at which the letters were presented varied during the administration. There were 6 blocks, with 3 sub-blocks, each containing 20 trials (letter presentations). The interstimulus intervals (ISIs) were 1, 2, and 4 seconds with a display time of 250 milliseconds. The order in which the different ISIs were presented varied between blocks. Conners' CCPT-II provides the following measures:% Omissions,% Commissions, Hit Reaction Time, Hit Reaction Time Standard Error,Variability of Standard Error, Detectability (d'), Response Style (beta), Perseverations, Hit Reaction Time Block Change (Vigilance Measure), Hit Standard Error Block Change (Vigilance Measure), Hit Reaction Time ISI change, and Hit Standard Error ISI Change, Confidence Index.
Time frame: Baseline and 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Commissions % Percentile | -5.980 percentage of score | Standard Deviation 29.332 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Detectability (d') Percentile | -3.614 percentage of score | Standard Deviation 33.471 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Hit RT ISI Change Percentile | 8.070 percentage of score | Standard Deviation 30.364 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Hit SE ISI Change Percentile | 8.270 percentage of score | Standard Deviation 35.78 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Omissions % Percentile | 10.285 percentage of score | Standard Deviation 29.39 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Hit RT Percentile | 5.933 percentage of score | Standard Deviation 27.606 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Hit RT Std Error Percentile | 8.747 percentage of score | Standard Deviation 30.776 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Variability Percentile | 8.781 percentage of score | Standard Deviation 32.543 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Responsive Style (beta) Percentile | -3.614 percentage of score | Standard Deviation 33.471 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Perseverations % Percentile | 4.807 percentage of score | Standard Deviation 25.389 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Hit RT Block Change Percentile | 0.213 percentage of score | Standard Deviation 33.614 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Hit SE Block Change Percentile | -2.919 percentage of score | Standard Deviation 36.037 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Conners' Continuous Performance Test II (CCPT II) | Confidence Index | 8.471 percentage of score | Standard Deviation 23.889 |
Secondary
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12
The PDSS total score ranges from a low of 0 where the individual is endorsing each item at the lowest level of daytime sleepiness to a high of 32 where the individual is endorsing each item at the highest level of daytime sleepiness.
Time frame: Baseline and 12 Months (from the 1st dose to the end of study)
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12 | -3.9 units on a scale | Standard Deviation 6 |
Secondary
Change From Baseline in Pediatric Quality of Life Scale
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. The Physical Summary Score is computed by summing values for questions 1, 2a, 2b, 3 and 5 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. The Psychosocial Summary Score is computed by summing questions 4, 6, 7, 8, and 9 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications.
Time frame: Baseline and 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Pediatric Quality of Life Scale | Physical Summary Score | -1.31 units on a scale | Standard Deviation 11.15 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Change From Baseline in Pediatric Quality of Life Scale | Psychosocial Summary Score | 2.14 units on a scale | Standard Deviation 10.37 |
Secondary
Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12
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 and 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12 | From Parent | 2.6 units on a scale | Standard Deviation 1.4 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12 | From Child | 2.6 units on a scale | Standard Deviation 1.5 |
Secondary
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses
The C-SSRS is a physician-completed scale to assess any suicidal ideation and suicidal behavior. The C-SSRS contained questions about suicidal behavior and suicidal ideation. Subjects were placed into categories for suicidal behavior and for suicidal ideation based on their responses to various questions. Any suicidality was defined as suicidal behavior or suicidal ideation. The suicidal behavior categories were determined based on the response to the questions under suicidal behavior (Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior).The suicidal ideation categories were determined by examining the response to 5 questions under suicidal ideation (Wish to be Dead, Nonspecific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent).
Time frame: 12 Months
Population: Intent to treat population
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Any Suicidality | 4 Subjects | 1.3 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Any Suicidal Behavior | 1 Subjects | 0.3 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Actual Attempt | 0 Subjects | 0 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Interrupted Attempt | 0 Subjects | 0 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Aborted Attempt | 1 Subjects | 0.3 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Preparatory Acts or Behavior | 0 Subjects | 0 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Any Suicidal Ideation | 4 Subjects | 1.3 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Wish to be Dead | 0 Subjects | 0 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Non-specific Active Suicidal Thoughts | 3 Subjects | 1 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Active Suicidal Ideation without Intent to Act | 0 Subjects | 0 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Active Suicidal Ideation w/ Some Intent to Act | 0 Subjects | 0 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Completed Suicide | 0 Subjects | 0 |
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses | Active Suicidal Ideation w/ Specific Plan | 1 Subjects | 0.3 |
Secondary
Overall Incidence of Skin Reactions: Number of Events
Time frame: 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Overall Incidence of Skin Reactions: Number of Events | 17 Events |
Secondary
Overall Incidence of Skin Reactions: Number of Participant Affected
Time frame: 12 Months (from the 1st dose to the end of study)
Population: Intent to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) | Overall Incidence of Skin Reactions: Number of Participant Affected | 13 participants |