Trial Outcomes & Findings for Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

486 participants

Primary outcome timeframe

Baseline (Day 0) to Week 12

Results posted on

2013-06-17

Participant Flow

Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of participants in the Baseline Characteristics refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period. Three subjects did not receive study medication.

Participant milestones

Participant milestones
Measure	Pooled High Dose Eszopiclone 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo Placebo 6-17 years
Overall Study STARTED	162	163	161
Overall Study COMPLETED	126	122	123
Overall Study NOT COMPLETED	36	41	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Pooled High Dose Eszopiclone 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo Placebo 6-17 years
Overall Study Adverse Event	5	5	3
Overall Study Lost to Follow-up	6	3	5
Overall Study Physician Decision	0	3	1
Overall Study Protocol Violation	1	2	1
Overall Study Withdrawal by Subject	13	16	15
Overall Study Other	11	12	13

Baseline Characteristics

Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pooled High Dose Eszopiclone n=160 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily. This included only patients that were randomized (ITT population).	Pooled Low Dose Eszopiclone n=163 Participants 1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily. This includes only patients that were randomized (ITT population).	Placebo n=160 Participants Placebo Once Daily. This included only patients that were randomized (ITT population).	Total n=483 Participants Total of all reporting groups
Age, Categorical <=18 years	160 Participants n=5 Participants	163 Participants n=7 Participants	160 Participants n=5 Participants	483 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	00 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	11.3 years STANDARD_DEVIATION 3.0 • n=5 Participants	11.4 years STANDARD_DEVIATION 3.0 • n=7 Participants	11.6 years STANDARD_DEVIATION 3.0 • n=5 Participants	11.5 years STANDARD_DEVIATION 3.0 • n=4 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	60 Participants n=7 Participants	59 Participants n=5 Participants	175 Participants n=4 Participants
Sex: Female, Male Male	104 Participants n=5 Participants	103 Participants n=7 Participants	101 Participants n=5 Participants	308 Participants n=4 Participants
Region of Enrollment United States	160 participants n=5 Participants	163 participants n=7 Participants	160 participants n=5 Participants	483 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat (ITT) population with both baseline and week 12 LPS. ITT refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.

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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=123 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).	-18.33 minutes Standard Error 3.91	-23.45 minutes Standard Error 3.91	-25.66 minutes Standard Error 3.92

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=123 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)	-23.35 Minutes Standard Error 3.40	-16.75 Minutes Standard Error 3.41	-17.30 Minutes Standard Error 3.43

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with Week 12 CGI Improvement from Parent/Caregiver

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).

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=126 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=123 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12	2.3 Units on a scale Standard Error 0.1	2.6 Units on a scale Standard Error 0.1	2.7 Units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with Week 12 CGI Improvement from Child

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).

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=126 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=123 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline in CGI-Child at Week 12	2.3 Units on a scale Standard Error 0.1	2.5 Units on a scale Standard Error 0.1	2.7 Units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 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)\].

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=126 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=120 Participants Placebo 6-17 years
Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.	-8.8 units on a scale Standard Error 1.0	-5.8 units on a scale Standard Error 1.0	-7.1 units on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 Subjective 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=122 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=121 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline to Week 12 in Subjective SL (Sleep Latency)	0.5 Minutes Standard Error 1.1	0.6 Minutes Standard Error 1.1	0.6 Minutes Standard Error 1.1

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 subjective 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=122 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=120 Participants Placebo 6-17 years
Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).	0.2 Minutes Standard Error 1.2	0.3 Minutes Standard Error 1.2	0.3 Minutes Standard Error 1.2

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 PSG defined sleep efficiency

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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=124 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)	7.31 percentage of SE Standard Error 1.07	7.40 percentage of SE Standard Error 1.08	7.94 percentage of SE Standard Error 1.08

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 PSG defined of Awakenings After Sleep Onset

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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=123 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).	-2.0 Number of Awakenings after sleep onse Standard Error 0.4	-1.5 Number of Awakenings after sleep onse Standard Error 0.4	-0.7 Number of Awakenings after sleep onse Standard Error 0.4

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 PSG defined Total Sleep Time

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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=124 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)	36.90 Minutes Standard Error 6.01	37.78 Minutes Standard Error 6.05	35.38 Minutes Standard Error 6.07

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 subjective Total Sleep Time

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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=121 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=123 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=122 Participants Placebo 6-17 years
Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).	77.2 Minutes Standard Error 8.0	66.4 Minutes Standard Error 8.0	49.2 Minutes Standard Error 8.0

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 11

Population: The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=85 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=83 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=98 Participants Placebo 6-17 years
Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.	0.90 Minutes Standard Error 1.12	0.81 Minutes Standard Error 1.12	0.93 Minutes Standard Error 1.13

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 11

Population: Actigraphy population which included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=85 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=83 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=98 Participants Placebo 6-17 years
Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.	0.94 Minutes Standard Error 1.06	1.02 Minutes Standard Error 1.06	0.99 Minutes Standard Error 1.07

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 11

Population: The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=85 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=83 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=98 Participants Placebo 6-17 years
Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.	-4.72 Minutes Standard Error 8.38	1.63 Minutes Standard Error 8.28	-6.02 Minutes Standard Error 8.74

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=126 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=120 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.	-4.5 units on a scale Standard Error 0.5	-4.0 units on a scale Standard Error 0.5	-3.5 units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=126 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=122 Participants Placebo 6-17 years
Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.	2.2 Score Standard Error 3.3	2.1 Score Standard Error 3.9	2.6 Score Standard Error 5.3

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=123 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=121 Participants Placebo 6-17 years
Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10). Physical	4.40 units on a scale Standard Error 0.64	3.07 units on a scale Standard Error 0.64	4.07 units on a scale Standard Error 0.65
Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10). Psychosocial	2.234 units on a scale Standard Error 0.562	1.347 units on a scale Standard Error 0.566	-0.121 units on a scale Standard Error 0.569

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population with both baseline and Week 12 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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=123 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=122 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=122 Participants Placebo 6-17 years
Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).	-1.1 Number of Awakenings Standard Error 0.1	-0.8 Number of Awakenings Standard Error 0.1	-1.0 Number of Awakenings Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=160 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=163 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=160 Participants Placebo 6-17 years
Change in School Tardiness/Attendance Reports at Week 12 (Days) Number of Days Tardy	-0.4 Days Standard Error 0.1	-0.2 Days Standard Error 0.1	-0.3 Days Standard Error 0.1
Change in School Tardiness/Attendance Reports at Week 12 (Days) Number of Days of Partial Attendance	0.1 Days Standard Error 0.1	-0.2 Days Standard Error 0.1	-0.1 Days Standard Error 0.1
Change in School Tardiness/Attendance Reports at Week 12 (Days) Number of Days Absent	0.0 Days Standard Error 0.08	-0.2 Days Standard Error 1.2	0.3 Days Standard Error 2.0

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Pooled High Dose Eszopiclone n=160 Participants 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=163 Participants 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=160 Participants Placebo 6-17 years
Change in School Tardiness/Attendance Reports at Week 12 (Hours)	-0.10 Hours Standard Error 0.05	-0.12 Hours Standard Error 0.05	-0.12 Hours Standard Error 0.05

Adverse Events

Pooled High Dose Eszopiclone

Serious events: 2 serious events

Other events: 72 other events

Deaths: 0 deaths

Pooled Low Dose Eszopiclone

Serious events: 0 serious events

Other events: 68 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pooled High Dose Eszopiclone n=159 participants at risk 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Pooled Low Dose Eszopiclone n=163 participants at risk 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo n=161 participants at risk Placebo 6-17 years once daily
Nervous system disorders Sedation	0.63% 1/159 • Number of events 1 Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of Participants at Risk in this adverse event section refers to the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.	0.00% 0/163 Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of Participants at Risk in this adverse event section refers to the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.	0.00% 0/161 Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of Participants at Risk in this adverse event section refers to the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.63% 1/159 • Number of events 1 Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of Participants at Risk in this adverse event section refers to the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.	0.00% 0/163 Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of Participants at Risk in this adverse event section refers to the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.	0.00% 0/161 Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of Participants at Risk in this adverse event section refers to the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.

Other adverse events

Additional Information

CNS Medical Director

Sunovion

Phone: 866-503-6357

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Trial Outcomes & Findings for Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia (NCT NCT00856973)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

Adverse Events

Pooled High Dose Eszopiclone

Pooled Low Dose Eszopiclone

Placebo

Serious adverse events

Other adverse events

Additional Information

CNS Medical Director

Results disclosure agreements