Trial Outcomes & Findings for An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers. (NCT NCT00699608)
NCT ID: NCT00699608
Last Updated: 2012-06-05
Results Overview
Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.
COMPLETED
PHASE3
91 participants
7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)
2012-06-05
Participant Flow
Participant milestones
| Measure |
Eszopiclone First, Zopiclone Second, Placebo Third
3 mg eszopiclone during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
|
Eszopiclone First, Placebo Second, Zopiclone Third
3 mg eszopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
|
Zopiclone First, Eszopiclone Second, Placebo Third
7.5 mg zopiclone during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
|
Zopiclone First, Placebo Second, Eszopiclone Third
7.5 mg zopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
|
Placebo First, Eszopiclone Second, Zopiclone Third
Placebo during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
|
Placebo First, Zopiclone Second, Eszopiclone Third
Placebo during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
16
|
15
|
15
|
15
|
15
|
15
|
|
First Intervention
COMPLETED
|
16
|
15
|
14
|
15
|
14
|
15
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
|
First 4-14 Day Washout Period
STARTED
|
16
|
15
|
14
|
15
|
14
|
15
|
|
First 4-14 Day Washout Period
COMPLETED
|
16
|
15
|
14
|
15
|
14
|
15
|
|
First 4-14 Day Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
16
|
15
|
14
|
15
|
14
|
15
|
|
Second Intervention
COMPLETED
|
16
|
15
|
13
|
14
|
14
|
15
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Second 4-14 Day Washout Period
STARTED
|
16
|
15
|
13
|
14
|
14
|
15
|
|
Second 4-14 Day Washout Period
COMPLETED
|
16
|
15
|
13
|
14
|
14
|
15
|
|
Second 4-14 Day Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
16
|
15
|
13
|
14
|
14
|
15
|
|
Third Intervention
COMPLETED
|
16
|
15
|
13
|
14
|
14
|
15
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Eszopiclone First, Zopiclone Second, Placebo Third
3 mg eszopiclone during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
|
Eszopiclone First, Placebo Second, Zopiclone Third
3 mg eszopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
|
Zopiclone First, Eszopiclone Second, Placebo Third
7.5 mg zopiclone during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
|
Zopiclone First, Placebo Second, Eszopiclone Third
7.5 mg zopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
|
Placebo First, Eszopiclone Second, Zopiclone Third
Placebo during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
|
Placebo First, Zopiclone Second, Eszopiclone Third
Placebo during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
|
|---|---|---|---|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Intervention
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Second Intervention
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Second Intervention
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=91 Participants
|
|---|---|
|
Age Continuous
|
29.8 years
STANDARD_DEVIATION 3.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
63 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian Heritage
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all subjects who gave informed consent, were randomised, and received at least one dose of double-blind medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Mean Tracking Error Assessed During the Continuous Tracking Test (CTT)
|
10.29 pixels
Standard Error 0.625
|
12.49 pixels
Standard Error 0.634
|
13.48 pixels
Standard Error 0.621
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) . The CTT is a task (8 minute duration) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the MTE, the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Mean Tracking Error (MTE) Assessed During the CTT
9.5 hours post-dose
|
10.44 pixels
Standard Error 1.108
|
13.50 pixels
Standard Error 1.121
|
13.55 pixels
Standard Error 1.101
|
|
Mean Tracking Error (MTE) Assessed During the CTT
7.5 hours post-dose
|
10.20 pixels
Standard Error 0.596
|
12.80 pixels
Standard Error 0.602
|
13.07 pixels
Standard Error 0.592
|
|
Mean Tracking Error (MTE) Assessed During the CTT
8 hours post-dose
|
9.70 pixels
Standard Error 0.830
|
12.72 pixels
Standard Error 0.840
|
13.15 pixels
Standard Error 0.826
|
|
Mean Tracking Error (MTE) Assessed During the CTT
8.5 hours post-dose
|
10.08 pixels
Standard Error 0.917
|
12.54 pixels
Standard Error 0.928
|
12.93 pixels
Standard Error 0.913
|
|
Mean Tracking Error (MTE) Assessed During the CTT
9 hours post-dose
|
11.02 pixels
Standard Error 0.214
|
13.00 pixels
Standard Error 1.229
|
14.81 pixels
Standard Error 1.208
|
|
Mean Tracking Error (MTE) Assessed During the CTT
10 hours post-dose
|
10.12 pixels
Standard Error 1.057
|
12.85 pixels
Standard Error 1.069
|
12.53 pixels
Standard Error 1.051
|
|
Mean Tracking Error (MTE) Assessed During the CTT
10.5 hours post-dose
|
9.48 pixels
Standard Error 0.757
|
11.38 pixels
Standard Error 0.767
|
11.84 pixels
Standard Error 0.753
|
|
Mean Tracking Error (MTE) Assessed During the CTT
11 hours post-dose
|
10.55 pixels
Standard Error 0.822
|
10.86 pixels
Standard Error 0.833
|
11.65 pixels
Standard Error 0.818
|
|
Mean Tracking Error (MTE) Assessed During the CTT
11.5 hours post-dose
|
9.18 pixels
Standard Error 0.523
|
10.06 pixels
Standard Error 0.530
|
10.30 pixels
Standard Error 0.521
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) A further outcome derived from the CTT is a peripheral awareness task where the participant responds to a stimulus presented in the periphery of vision, while simultaneously attending to the tracking test. The mean reaction time, in milliseconds, to these stimuli over the trial period is taken as the response measure for this component of the divided attention task. A lower mean reaction time is indicative of better peripheral awareness.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
CTT Mean Reaction Time
7.5 hours post-dose, n=89, 87, 90
|
746.88 milliseconds
Standard Error 10.36
|
791.99 milliseconds
Standard Error 10.40
|
806.31 milliseconds
Standard Error 10.33
|
|
CTT Mean Reaction Time
8 hours post-dose, n=88, 87, 90
|
744.90 milliseconds
Standard Error 10.44
|
787.41 milliseconds
Standard Error 10.50
|
799.53 milliseconds
Standard Error 10.40
|
|
CTT Mean Reaction Time
8.5 hours post-dose, n=89, 87, 90
|
757.72 milliseconds
Standard Error 10.44
|
793.18 milliseconds
Standard Error 10.51
|
797.92 milliseconds
Standard Error 10.39
|
|
CTT Mean Reaction Time
9 hours post-dose, n=89, 87, 90
|
760.11 milliseconds
Standard Error 10.75
|
802.53 milliseconds
Standard Error 10.81
|
811.11 milliseconds
Standard Error 10.69
|
|
CTT Mean Reaction Time
9.5 hours post-dose, n=89, 87, 90
|
763.65 milliseconds
Standard Error 10.17
|
793.69 milliseconds
Standard Error 10.23
|
789.63 milliseconds
Standard Error 10.13
|
|
CTT Mean Reaction Time
10 hours post-dose, n=89, 87, 90
|
756.67 milliseconds
Standard Error 10.54
|
778.09 milliseconds
Standard Error 10.60
|
792.00 milliseconds
Standard Error 10.48
|
|
CTT Mean Reaction Time
10.5 hours post-dose, n=89, 87, 90
|
765.98 milliseconds
Standard Error 10.55
|
774.06 milliseconds
Standard Error 10.59
|
779.80 milliseconds
Standard Error 10.51
|
|
CTT Mean Reaction Time
11 hours post-dose, n=89, 87, 90
|
762.43 milliseconds
Standard Error 9.88
|
760.29 milliseconds
Standard Error 9.95
|
765.56 milliseconds
Standard Error 9.85
|
|
CTT Mean Reaction Time
11.5 hours post-dose, n=89, 87, 90
|
745.26 milliseconds
Standard Error 9.48
|
750.79 milliseconds
Standard Error 9.52
|
766.44 milliseconds
Standard Error 9.44
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Critical Flicker Fusion (CFF) is a validated cognitive assessment task that provides an index of central nervous system (CNS) activity and attention modulated motion detection. Participants are required to discriminate flicker from fusion, and vice versa, in a set of four light-emitting diodes arranged in a one-centimetre square. These diodes are held in foveal fixation when viewed at a distance of one metre. Individual thresholds are determined on four ascending and four descending scales. The mean of the four ascending presentations give the ascending threshold frequency in hertz.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Critical Flicker Fusion Test-Ascending Threshold
7.5 hours post-dose, n=88, 87, 90
|
30.65 hertz
Standard Error 0.24
|
30.84 hertz
Standard Error 0.24
|
30.93 hertz
Standard Error 0.24
|
|
Critical Flicker Fusion Test-Ascending Threshold
8 hours post-dose, n=89, 87, 90
|
30.31 hertz
Standard Error 0.24
|
30.30 hertz
Standard Error 0.24
|
30.41 hertz
Standard Error 0.24
|
|
Critical Flicker Fusion Test-Ascending Threshold
8.5 hours post-dose, n=89, 87, 90
|
30.27 hertz
Standard Error 0.22
|
29.98 hertz
Standard Error 0.22
|
30.17 hertz
Standard Error 0.22
|
|
Critical Flicker Fusion Test-Ascending Threshold
9 hours post-dose, n=89, 87, 90
|
30.10 hertz
Standard Error 0.23
|
29.90 hertz
Standard Error 0.23
|
30.00 hertz
Standard Error 0.23
|
|
Critical Flicker Fusion Test-Ascending Threshold
9.5 hours post-dose, n=89, 87, 90
|
30.18 hertz
Standard Error 0.23
|
29.99 hertz
Standard Error 0.23
|
30.05 hertz
Standard Error 0.23
|
|
Critical Flicker Fusion Test-Ascending Threshold
10 hours post-dose, n=89, 87, 90
|
30.20 hertz
Standard Error 0.24
|
29.91 hertz
Standard Error 0.24
|
29.97 hertz
Standard Error 0.23
|
|
Critical Flicker Fusion Test-Ascending Threshold
10.5 hours post-dose, n=89, 87, 89
|
30.26 hertz
Standard Error 0.21
|
29.99 hertz
Standard Error 0.22
|
30.16 hertz
Standard Error 0.21
|
|
Critical Flicker Fusion Test-Ascending Threshold
11 hours post-dose, n=89, 87, 90
|
30.20 hertz
Standard Error 0.23
|
30.06 hertz
Standard Error 0.23
|
30.04 hertz
Standard Error 0.23
|
|
Critical Flicker Fusion Test-Ascending Threshold
11.5 hours post-dose, n=89, 87, 90
|
30.31 hertz
Standard Error 0.22
|
30.28 hertz
Standard Error 0.23
|
30.56 hertz
Standard Error 0.22
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four descending presentations from the CFF give the descending threshold frequency in hertz.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Critical Flicker Fusion Test -Descending Threshold
7.5 hours post-dose, n=88, 87, 90
|
29.06 hertz
Standard Error 0.35
|
28.37 hertz
Standard Error 0.35
|
28.05 hertz
Standard Error 0.35
|
|
Critical Flicker Fusion Test -Descending Threshold
8 hours post-dose, n=89, 87, 90
|
28.52 hertz
Standard Error 0.33
|
27.95 hertz
Standard Error 0.33
|
27.95 hertz
Standard Error 0.33
|
|
Critical Flicker Fusion Test -Descending Threshold
8.5 hours post-dose, n=89, 87, 90
|
28.42 hertz
Standard Error 0.34
|
27.75 hertz
Standard Error 0.35
|
27.59 hertz
Standard Error 0.34
|
|
Critical Flicker Fusion Test -Descending Threshold
9 hours post-dose, n=89, 87, 90
|
28.07 hertz
Standard Error 0.34
|
27.64 hertz
Standard Error 0.35
|
27.89 hertz
Standard Error 0.34
|
|
Critical Flicker Fusion Test -Descending Threshold
9.5 hours post-dose, n=89, 87, 90
|
28.19 hertz
Standard Error 0.34
|
27.81 hertz
Standard Error 0.35
|
27.75 hertz
Standard Error 0.34
|
|
Critical Flicker Fusion Test -Descending Threshold
10 hours post-dose, n=89, 87, 90
|
28.18 hertz
Standard Error 0.34
|
27.96 hertz
Standard Error 0.34
|
28.06 hertz
Standard Error 0.34
|
|
Critical Flicker Fusion Test -Descending Threshold
10.5 hours post-dose, n=89, 87, 89
|
28.48 hertz
Standard Error 0.34
|
27.99 hertz
Standard Error 0.34
|
28.10 hertz
Standard Error 0.34
|
|
Critical Flicker Fusion Test -Descending Threshold
11 hours post-dose, n=89, 87, 90
|
28.53 hertz
Standard Error 0.34
|
28.03 hertz
Standard Error 0.34
|
28.20 hertz
Standard Error 0.34
|
|
Critical Flicker Fusion Test -Descending Threshold
11.5 hours post-dose, n=89, 87, 90
|
28.57 hertz
Standard Error 0.33
|
28.69 hertz
Standard Error 0.34
|
28.48 hertz
Standard Error 0.33
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four ascending and four descending presentations of the CFF give the overall threshold frequency in hertz.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Critical Flicker Fusion Test-Overall Threshold
11.5 hours post-dose, n=89, 87, 90
|
29.46 hertz
Standard Error 0.24
|
29.50 hertz
Standard Error 0.25
|
29.53 hertz
Standard Error 0.24
|
|
Critical Flicker Fusion Test-Overall Threshold
7.5 hours post-dose, n=88, 87, 90
|
29.82 hertz
Standard Error 0.26
|
29.57 hertz
Standard Error 0.26
|
29.45 hertz
Standard Error 0.26
|
|
Critical Flicker Fusion Test-Overall Threshold
8 hours post-dose, n=89, 87, 90
|
29.41 hertz
Standard Error 0.25
|
29.11 hertz
Standard Error 0.25
|
29.00 hertz
Standard Error 0.24
|
|
Critical Flicker Fusion Test-Overall Threshold
8.5 hours post-dose, n=89, 87, 90
|
29.36 hertz
Standard Error 0.25
|
28.86 hertz
Standard Error 0.25
|
28.88 hertz
Standard Error 0.25
|
|
Critical Flicker Fusion Test-Overall Threshold
9 hours post-dose, n=89, 87, 90
|
29.10 hertz
Standard Error 0.25
|
28.79 hertz
Standard Error 0.25
|
28.96 hertz
Standard Error 0.25
|
|
Critical Flicker Fusion Test-Overall Threshold
9.5 hours post-dose, n=89, 87, 90
|
29.19 hertz
Standard Error 0.25
|
28.90 hertz
Standard Error 0.25
|
28.90 hertz
Standard Error 0.25
|
|
Critical Flicker Fusion Test-Overall Threshold
10 hours post-dose, n=89, 87, 90
|
29.20 hertz
Standard Error 0.25
|
28.95 hertz
Standard Error 0.25
|
29.02 hertz
Standard Error 0.25
|
|
Critical Flicker Fusion Test-Overall Threshold
10.5 hours post-dose, n=89, 87, 89
|
29.38 hertz
Standard Error 0.24
|
29.00 hertz
Standard Error 0.24
|
29.14 hertz
Standard Error 0.24
|
|
Critical Flicker Fusion Test-Overall Threshold
11 hours post-dose, n=89, 87, 90
|
29.37 hertz
Standard Error 0.25
|
29.07 hertz
Standard Error 0.25
|
29.14 hertz
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
7.5 hours post-dose, n=89, 87, 90
|
68.2 number of substitutions
Standard Error 1.09
|
64.7 number of substitutions
Standard Error 1.10
|
63.4 number of substitutions
Standard Error 1.09
|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
8 hours post-dose, n=87, 84, 88
|
70.4 number of substitutions
Standard Error 1.16
|
66.5 number of substitutions
Standard Error 1.17
|
65.6 number of substitutions
Standard Error 1.15
|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
8.5 hours post-dose, n=89, 87, 90
|
70.6 number of substitutions
Standard Error 1.13
|
67.4 number of substitutions
Standard Error 1.13
|
66.3 number of substitutions
Standard Error 1.12
|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
9 hours post-dose, n=88, 87, 90
|
68.1 number of substitutions
Standard Error 1.20
|
65.2 number of substitutions
Standard Error 1.20
|
64.2 number of substitutions
Standard Error 1.19
|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
9.5 hours post-dose, n=88, 87, 90
|
70.2 number of substitutions
Standard Error 1.12
|
67.2 number of substitutions
Standard Error 1.13
|
66.5 number of substitutions
Standard Error 1.12
|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
10 hours post-dose, n=89, 87, 90
|
70.9 number of substitutions
Standard Error 1.14
|
68.2 number of substitutions
Standard Error 1.14
|
67.6 number of substitutions
Standard Error 1.13
|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
10.5 hours post-dose, n=86, 85, 88
|
71.8 number of substitutions
Standard Error 1.16
|
69.7 number of substitutions
Standard Error 1.17
|
67.8 number of substitutions
Standard Error 1.16
|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
11 hours post-dose, n=88, 87, 90
|
70.9 number of substitutions
Standard Error 1.11
|
68.1 number of substitutions
Standard Error 1.11
|
67.6 number of substitutions
Standard Error 1.10
|
|
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
11.5 hours post-dose, n=89, 87, 90
|
69.0 number of substitutions
Standard Error 1.16
|
68.0 number of substitutions
Standard Error 1.17
|
68.3 number of substitutions
Standard Error 1.16
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
7.5 hours post-dose, n=89, 87, 90
|
67.9 number of substitutions
Standard Error 1.10
|
64.3 number of substitutions
Standard Error 1.10
|
63.0 number of substitutions
Standard Error 1.10
|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
8 hours post-dose, n=87, 84, 88
|
70.2 number of substitutions
Standard Error 1.16
|
66.2 number of substitutions
Standard Error 1.17
|
65.2 number of substitutions
Standard Error 1.16
|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
8.5 hours post-dose, n=89, 87, 90
|
70.4 number of substitutions
Standard Error 1.13
|
67.0 number of substitutions
Standard Error 1.14
|
66.0 number of substitutions
Standard Error 1.13
|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
9 hours post-dose, n=88, 87, 90
|
67.9 number of substitutions
Standard Error 1.20
|
64.8 number of substitutions
Standard Error 1.21
|
63.8 number of substitutions
Standard Error 1.20
|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
9.5 hours post-dose, n=88, 87, 90
|
69.9 number of substitutions
Standard Error 1.12
|
66.9 number of substitutions
Standard Error 1.13
|
66.2 number of substitutions
Standard Error 1.12
|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
10 hours post-dose, n=89, 87, 90
|
70.8 number of substitutions
Standard Error 1.14
|
68.0 number of substitutions
Standard Error 1.15
|
67.3 number of substitutions
Standard Error 1.14
|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
10.5 hours post-dose, n=86, 85, 88
|
71.5 number of substitutions
Standard Error 1.17
|
69.5 number of substitutions
Standard Error 1.17
|
67.4 number of substitutions
Standard Error 1.16
|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
11 hours post-dose, n=88, 87, 90
|
70.6 number of substitutions
Standard Error 1.11
|
67.8 number of substitutions
Standard Error 1.11
|
67.3 number of substitutions
Standard Error 1.10
|
|
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
11.5 hours post-dose, n=89, 87, 90
|
68.7 number of substitutions
Standard Error 1.16
|
67.8 number of substitutions
Standard Error 1.17
|
68.0 number of substitutions
Standard Error 1.12
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
The N-Back task requires the participant to indicate, using the mouse, whether the current stimulus presented on the screen and the one immediately before it visually match (i.e., "one-back"). In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of "match" trials to non-match trials. The duration of the test is 2 minutes. The percentage of correct responses is the percentage of correct responses given in 2 minutes.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
1-Back Percentage of Correct Responses
8.5 hours post-dose, n=89, 87, 90
|
93.6 percentage of responses
Standard Error 1.05
|
92.8 percentage of responses
Standard Error 1.06
|
89.6 percentage of responses
Standard Error 1.05
|
|
1-Back Percentage of Correct Responses
7.5 hours post-dose, n=87, 87, 88
|
93.9 percentage of responses
Standard Error 0.95
|
92.2 percentage of responses
Standard Error 0.96
|
90.4 percentage of responses
Standard Error 0.95
|
|
1-Back Percentage of Correct Responses
8 hours post-dose, n=89, 87, 89
|
93.3 percentage of responses
Standard Error 0.97
|
92.0 percentage of responses
Standard Error 0.98
|
89.5 percentage of responses
Standard Error 0.97
|
|
1-Back Percentage of Correct Responses
9 hours post-dose, n=89, 87, 90
|
93.5 percentage of responses
Standard Error 1.07
|
91.6 percentage of responses
Standard Error 1.08
|
89.4 percentage of responses
Standard Error 1.07
|
|
1-Back Percentage of Correct Responses
9.5 hours post-dose, n=89, 86, 90
|
92.9 percentage of responses
Standard Error 1.02
|
91.2 percentage of responses
Standard Error 1.02
|
90.7 percentage of responses
Standard Error 1.01
|
|
1-Back Percentage of Correct Responses
10 hours post-dose, n=89, 87, 90
|
93.0 percentage of responses
Standard Error 0.90
|
92.2 percentage of responses
Standard Error 0.91
|
92.0 percentage of responses
Standard Error 0.90
|
|
1-Back Percentage of Correct Responses
10.5 hours post-dose, n=89, 86, 89
|
94.4 percentage of responses
Standard Error 0.94
|
92.0 percentage of responses
Standard Error 0.95
|
91.7 percentage of responses
Standard Error 0.94
|
|
1-Back Percentage of Correct Responses
11 hours post-dose, n=89, 87, 90
|
93.0 percentage of responses
Standard Error 0.92
|
92.6 percentage of responses
Standard Error 0.93
|
91.9 percentage of responses
Standard Error 0.92
|
|
1-Back Percentage of Correct Responses
11.5 hours post-dose, n=89, 87, 90
|
93.4 percentage of responses
Standard Error 0.92
|
94.0 percentage of responses
Standard Error 0.92
|
92.0 percentage of responses
Standard Error 0.91
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). In "3-back" tasks, a comparison is made between the current stimulus and the two before the immediately preceding stimulus. In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of "match" trials to non-match trials. The duration of the test is 2 min. The percentage of correct responses is the percentage of correct responses given in 2 min.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
3-Back Percentage of Correct Responses
7.5 hours post-dose, n=87, 87, 88
|
84.6 percentage of responses
Standard Error 1.40
|
80.4 percentage of responses
Standard Error 1.41
|
76.9 percentage of responses
Standard Error 1.40
|
|
3-Back Percentage of Correct Responses
8 hours post-dose, n=89, 87, 89
|
83.5 percentage of responses
Standard Error 1.55
|
82.3 percentage of responses
Standard Error 1.56
|
76.8 percentage of responses
Standard Error 1.55
|
|
3-Back Percentage of Correct Responses
8.5 hours post-dose, n=89, 87, 90
|
82.4 percentage of responses
Standard Error 1.56
|
81.1 percentage of responses
Standard Error 1.57
|
78.3 percentage of responses
Standard Error 1.55
|
|
3-Back Percentage of Correct Responses
9 hours post-dose, n=89, 87, 90
|
83.3 percentage of responses
Standard Error 1.61
|
78.9 percentage of responses
Standard Error 1.62
|
77.3 percentage of responses
Standard Error 1.60
|
|
3-Back Percentage of Correct Responses
9.5 hours post-dose, n=89, 86, 90
|
82.1 percentage of responses
Standard Error 1.60
|
80.2 percentage of responses
Standard Error 1.61
|
76.9 percentage of responses
Standard Error 1.59
|
|
3-Back Percentage of Correct Responses
10 hours post-dose, n=89, 87, 90
|
83.4 percentage of responses
Standard Error 1.53
|
82.0 percentage of responses
Standard Error 1.54
|
79.2 percentage of responses
Standard Error 1.52
|
|
3-Back Percentage of Correct Responses
10.5 hours post-dose, n=89, 86, 89
|
82.6 percentage of responses
Standard Error 1.50
|
81.3 percentage of responses
Standard Error 1.51
|
79.7 percentage of responses
Standard Error 1.50
|
|
3-Back Percentage of Correct Responses
11 hours post-dose, n=89, 87, 90
|
81.7 percentage of responses
Standard Error 1.44
|
83.2 percentage of responses
Standard Error 1.45
|
79.8 percentage of responses
Standard Error 1.44
|
|
3-Back Percentage of Correct Responses
11.5 hours post-dose, n=89, 87, 90
|
82.9 percentage of responses
Standard Error 1.40
|
83.6 percentage of responses
Standard Error 1.41
|
81.1 percentage of responses
Standard Error 1.39
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
1-Back Reaction Time
7.5 hours post-dose, n=87, 87, 88
|
755.9 milliseconds
Standard Error 17.81
|
819.3 milliseconds
Standard Error 17.85
|
840.3 milliseconds
Standard Error 17.75
|
|
1-Back Reaction Time
8 hours post-dose, n=89, 87, 89
|
752.7 milliseconds
Standard Error 16.89
|
783.7 milliseconds
Standard Error 16.99
|
805.8 milliseconds
Standard Error 16.87
|
|
1-Back Reaction Time
8.5 hours post-dose, n=89, 87, 90
|
741.1 milliseconds
Standard Error 17.09
|
776.1 milliseconds
Standard Error 17.18
|
778.7 milliseconds
Standard Error 17.04
|
|
1-Back Reaction Time
9 hours post-dose, n=89, 87, 90
|
734.8 milliseconds
Standard Error 16.58
|
784.5 milliseconds
Standard Error 16.68
|
791.1 milliseconds
Standard Error 16.58
|
|
1-Back Reaction Time
9.5 hours post-dose, n=89, 86, 90
|
729.0 milliseconds
Standard Error 16.84
|
757.2 milliseconds
Standard Error 16.98
|
784.0 milliseconds
Standard Error 16.80
|
|
1-Back Reaction Time
10 hours post-dose, n=89, 87, 90
|
724.7 milliseconds
Standard Error 16.39
|
760.8 milliseconds
Standard Error 16.48
|
759.5 milliseconds
Standard Error 16.34
|
|
1-Back Reaction Time
10.5 hours post-dose, n=89, 86, 89
|
713.2 milliseconds
Standard Error 15.81
|
735.2 milliseconds
Standard Error 15.92
|
750.7 milliseconds
Standard Error 15.80
|
|
1-Back Reaction Time
11 hours post-dose, n=89, 87, 90
|
718.5 milliseconds
Standard Error 16.26
|
716.9 milliseconds
Standard Error 16.33
|
741.7 milliseconds
Standard Error 16.22
|
|
1-Back Reaction Time
11.5 hours post-dose, n=89, 87, 90
|
709.3 milliseconds
Standard Error 16.83
|
716.7 milliseconds
Standard Error 16.92
|
720.5 milliseconds
Standard Error 16.78
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
3-Back Reaction Time
11.5 hours post-dose, n=89, 87, 90
|
876.2 milliseconds
Standard Error 20.49
|
903.2 milliseconds
Standard Error 20.58
|
934.7 milliseconds
Standard Error 20.39
|
|
3-Back Reaction Time
7.5 hours post-dose, n=87, 87, 88
|
959.5 milliseconds
Standard Error 20.87
|
1020.9 milliseconds
Standard Error 20.87
|
1076.4 milliseconds
Standard Error 20.79
|
|
3-Back Reaction Time
8 hours post-dose, n=89, 87, 89
|
960.0 milliseconds
Standard Error 21.56
|
1018.5 milliseconds
Standard Error 21.62
|
1042.2 milliseconds
Standard Error 21.53
|
|
3-Back Reaction Time
8.5 hours post-dose, n=89, 87, 90
|
925.9 milliseconds
Standard Error 21.37
|
997.7 milliseconds
Standard Error 21.49
|
1024.2 milliseconds
Standard Error 21.33
|
|
3-Back Reaction Time
9 hours post-dose, n=89, 87, 90
|
916.9 milliseconds
Standard Error 21.50
|
1002.2 milliseconds
Standard Error 21.61
|
1007.8 milliseconds
Standard Error 21.46
|
|
3-Back Reaction Time
9.5 hours post-dose, n=89, 86, 90
|
932.9 milliseconds
Standard Error 21.86
|
992.1 milliseconds
Standard Error 22.05
|
978.0 milliseconds
Standard Error 21.81
|
|
3-Back Reaction Time
10 hours post-dose, n=89, 87, 90
|
907.4 milliseconds
Standard Error 21.26
|
948.7 milliseconds
Standard Error 21.36
|
987.5 milliseconds
Standard Error 21.19
|
|
3-Back Reaction Time
10.5 hours post-dose, n=89, 86, 89
|
900.3 milliseconds
Standard Error 20.92
|
961.5 milliseconds
Standard Error 21.08
|
945.2 milliseconds
Standard Error 20.89
|
|
3-Back Reaction Time
11 hours post-dose, n=89, 87, 90
|
915.3 milliseconds
Standard Error 19.61
|
935.5 milliseconds
Standard Error 19.70
|
940.4 milliseconds
Standard Error 19.54
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
The Linear Analogue Rating Scale (LARS) is used as a measure of the subjective effects of psychoactive drugs. Participants mark a series of 10 cm (100 unit line) analogue scales (1-100, 100 = most impaired) relating to dizzy, clumsy, anxious, relaxed, tired, drowsy, alert, energetic, sad, and depressed, indicating their present feeling with regard to a mid-point, representing their "usual" state of mind before treatment began. The higher the score, the more impaired the participant feels. The Tiredness, Alertness, Energy, and Drowsiness scores are averaged to derive an overall Sedation score.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
8 hours post-dose, n=89, 87, 90
|
54.54 points on a scale
Standard Error 1.37
|
56.40 points on a scale
Standard Error 1.15
|
59.21 points on a scale
Standard Error 1.13
|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
8.5 hours post-dose, n=89, 87, 90
|
54.07 points on a scale
Standard Error 1.18
|
54.39 points on a scale
Standard Error 1.19
|
56.93 points on a scale
Standard Error 1.18
|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
9 hours post-dose, n=89, 87, 90
|
53.63 points on a scale
Standard Error 1.12
|
54.93 points on a scale
Standard Error 1.12
|
56.01 points on a scale
Standard Error 1.10
|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
9.5 hours post-dose, n=89, 87, 90
|
53.84 points on a scale
Standard Error 1.14
|
55.39 points on a scale
Standard Error 1.15
|
55.90 points on a scale
Standard Error 1.13
|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
10 hours post-dose, n=89, 87, 90
|
53.98 points on a scale
Standard Error 1.21
|
54.68 points on a scale
Standard Error 1.23
|
55.73 points on a scale
Standard Error 1.21
|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
10.5 hours post-dose, n=89, 87, 90
|
51.77 points on a scale
Standard Error 1.21
|
53.77 points on a scale
Standard Error 1.13
|
55.31 points on a scale
Standard Error 1.12
|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
11 hours post-dose, n=89, 87, 90
|
51.47 points on a scale
Standard Error 1.06
|
51.49 points on a scale
Standard Error 1.06
|
52.79 points on a scale
Standard Error 1.05
|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
11.5 hours post-dose, n=89, 87, 90
|
49.02 points on a scale
Standard Error 1.21
|
49.41 points on a scale
Standard Error 1.22
|
51.24 points on a scale
Standard Error 1.20
|
|
Sedation Score, as Assessed by the Linear Analogue Rating Scales
7.5 hours post-dose, n=89, 87, 90
|
54.21 points on a scale
Standard Error 1.15
|
54.87 points on a scale
Standard Error 1.16
|
57.00 points on a scale
Standard Error 1.14
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Anxiety, Depression, Relaxed, and Sadness scores are averaged to derive an overall "Mood" score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
7.5 hours post-dose, n=89, 87, 90
|
47.75 points on a scale
Standard Error 0.71
|
48.13 points on a scale
Standard Error 0.72
|
48.03 points on a scale
Standard Error 0.71
|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
8 hours post-dose, n=89, 87, 90
|
49.19 points on a scale
Standard Error 0.71
|
48.42 points on a scale
Standard Error 0.71
|
49.11 points on a scale
Standard Error 0.70
|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
8.5 hours post-dose, n=89, 87, 90
|
48.88 points on a scale
Standard Error 0.70
|
48.42 points on a scale
Standard Error 0.70
|
48.30 points on a scale
Standard Error 0.69
|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
9 hours post-dose, n=89, 87, 90
|
48.48 points on a scale
Standard Error 0.74
|
47.67 points on a scale
Standard Error 0.75
|
48.61 points on a scale
Standard Error 0.74
|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
9.5 hours post-dose, n=89, 87, 90
|
48.30 points on a scale
Standard Error 0.75
|
47.89 points on a scale
Standard Error 0.76
|
47.54 points on a scale
Standard Error 0.75
|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
10 hours post-dose, n=89, 87, 90
|
47.98 points on a scale
Standard Error 0.79
|
48.25 points on a scale
Standard Error 0.79
|
48.28 points on a scale
Standard Error 0.78
|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
10.5 hours post-dose, n=89, 87, 90
|
47.57 points on a scale
Standard Error 0.87
|
48.72 points on a scale
Standard Error 0.88
|
48.47 points on a scale
Standard Error 0.87
|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
11 hours post-dose, n=89, 87, 90
|
47.45 points on a scale
Standard Error 0.85
|
47.07 points on a scale
Standard Error 0.86
|
47.90 points on a scale
Standard Error 0.85
|
|
Mood Score, as Assessed by the Linear Analogue Rating Scales
11.5 hours post-dose, n=89, 87, 90
|
45.63 points on a scale
Standard Error 1.03
|
47.09 points on a scale
Standard Error 1.40
|
46.08 points on a scale
Standard Error 1.03
|
SECONDARY outcome
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)Population: Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.
Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Dizziness and Clumsiness scores are averaged to derive an overall "Coordination" score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo
|
Eszopiclone
n=87 Participants
3 mg Eszopiclone
|
Zopiclone
n=90 Participants
7.5 mg Zopiclone
|
|---|---|---|---|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
7.5 hours post-dose, n=89, 87, 90
|
49.09 points on a scale
Standard Error 1.13
|
50.33 points on a scale
Standard Error 1.15
|
52.42 points on a scale
Standard Error 1.13
|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
8 hours post-dose, n=89, 87, 90
|
50.03 points on a scale
Standard Error 0.92
|
51.21 points on a scale
Standard Error 0.93
|
52.10 points on a scale
Standard Error 0.92
|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
8.5 hours post-dose, n=89, 87, 90
|
49.23 points on a scale
Standard Error 0.86
|
49.52 points on a scale
Standard Error 0.87
|
51.76 points on a scale
Standard Error 0.86
|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
9 hours post-dose, n=89, 87, 90
|
49.68 points on a scale
Standard Error 0.94
|
50.38 points on a scale
Standard Error 0.95
|
50.41 points on a scale
Standard Error 0.94
|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
9.5 hours post-dose, n=89, 87, 90
|
49.08 points on a scale
Standard Error 0.97
|
49.42 points on a scale
Standard Error 0.98
|
51.41 points on a scale
Standard Error 0.96
|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
10 hours post-dose, n=89, 87, 90
|
49.37 points on a scale
Standard Error 0.96
|
49.72 points on a scale
Standard Error 0.97
|
50.27 points on a scale
Standard Error 0.95
|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
10.5 hours post-dose, n=89, 87, 90
|
48.60 points on a scale
Standard Error 0.86
|
50.68 points on a scale
Standard Error 0.87
|
50.40 points on a scale
Standard Error 0.86
|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
11 hours post-dose, n=89, 87, 90
|
48.97 points on a scale
Standard Error 0.83
|
48.51 points on a scale
Standard Error 0.84
|
49.96 points on a scale
Standard Error 0.83
|
|
Coordination Score, as Assessed by the Linear Analogue Rating Scales
11.5 hours post-dose, n=89, 87, 90
|
48.20 points on a scale
Standard Error 0.82
|
47.45 points on a scale
Standard Error 0.83
|
49.82 points on a scale
Standard Error 0.81
|
Adverse Events
Placebo
Eszopiclone
Zopiclone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=89 participants at risk
Placebo
|
Eszopiclone
n=88 participants at risk
3 mg Eszopiclone
|
Zopiclone
n=90 participants at risk
7.5 mg Zopiclone
|
|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/89
|
30.7%
27/88
|
33.3%
30/90
|
|
Nervous system disorders
Somnolence
|
1.1%
1/89
|
12.5%
11/88
|
7.8%
7/90
|
|
Nervous system disorders
Dizziness
|
0.00%
0/89
|
4.5%
4/88
|
5.6%
5/90
|
|
Nervous system disorders
Headache
|
2.2%
2/89
|
2.3%
2/88
|
2.2%
2/90
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/89
|
2.3%
2/88
|
3.3%
3/90
|
|
Nervous system disorders
Paraesthesia
|
1.1%
1/89
|
0.00%
0/88
|
1.1%
1/90
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/89
|
0.00%
0/88
|
1.1%
1/90
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/89
|
0.00%
0/88
|
1.1%
1/90
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/89
|
0.00%
0/88
|
1.1%
1/90
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
General disorders
Fatigue
|
4.5%
4/89
|
6.8%
6/88
|
6.7%
6/90
|
|
General disorders
Asthenia
|
0.00%
0/89
|
1.1%
1/88
|
1.1%
1/90
|
|
Gastrointestinal disorders
Nausea
|
3.4%
3/89
|
4.5%
4/88
|
4.4%
4/90
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/89
|
0.00%
0/88
|
0.00%
0/90
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/89
|
0.00%
0/88
|
1.1%
1/90
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/89
|
2.3%
2/88
|
0.00%
0/90
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/89
|
2.3%
2/88
|
0.00%
0/90
|
|
Psychiatric disorders
Depressed mood
|
1.1%
1/89
|
0.00%
0/88
|
0.00%
0/90
|
|
Psychiatric disorders
Fear
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Psychiatric disorders
Somnambulism
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/89
|
0.00%
0/88
|
1.1%
1/90
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/89
|
2.3%
2/88
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Eye disorders
Eye pain
|
0.00%
0/89
|
1.1%
1/88
|
1.1%
1/90
|
|
Eye disorders
Eye pruritis
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/89
|
1.1%
1/88
|
1.1%
1/90
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/89
|
1.1%
1/88
|
0.00%
0/90
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/89
|
0.00%
0/88
|
1.1%
1/90
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/89
|
0.00%
0/88
|
1.1%
1/90
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER