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A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
This study has been completed.
Study NCT00386334   Information provided by Sepracor, Inc.
First Received: October 9, 2006   Last Updated: June 16, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Condition: Insomnia
Interventions: Drug: Eszopiclone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
823 participants were screened. Two participants in each arm completed all assessments for the double blind period but discontinued before starting the follow up period (withdrew consent; did not take any single blind medication in follow up period).

Reporting Groups
  Description
Placebo Placebo tablets
Eszopiclone Eszopiclone 2 mg tablets

Participant Flow for 2 periods
Period:   Double Blind Period
  Placebo Eszopiclone
STARTED   194     194  
COMPLETED   148     147  
NOT COMPLETED   46     47  
      Adverse Event               9                 14  
      Protocol Violation               1                 1  
      Withdrawal by Subject               9                 13  
      Lack of Efficacy               20                 11  
      Didnt Meet Entry/Randomization Criteria               4                 5  
      Others               3                 3  

Period:   Follow up:2 Week Placebo, 2 Week no Drug
  Placebo Eszopiclone
STARTED   146[1]   145[2]
COMPLETED   143     144  
NOT COMPLETED   3     1  
      Withdrawal by Subject               3                 1  
[1] Two subjects withdrew consent prior to starting the follow up period.
[2] Two subjects withdrew consent prior to starting the follow up period.



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Placebo tablets
Eszopiclone Eszopiclone 2 mg tablets

Baseline Measures
  Placebo Eszopiclone Total
Number of Participants  
[units: participants]
 		194 194 388
Age  
[units: participants]
 		     
<=18 years 0 0 0
Between 18 and 65 years 0 0 0
>=65 years 194 194 388
Age  
[units: years]
Mean ± Standard Deviation 		72.4 ± 5.2 71.6 ± 5.0 72.0 ± 5.1
Gender  
[units: participants]
 		     
Female 119 124 243
Male 75 70 145
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native 0 1 1
Asian 2 4 6
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 9 8 17
White 181 178 359
More than one race 0 0 0
Unknown or Not Reported 2 2 4
Region of Enrollment  
[units: participants]
 		     
United States 194 194 388
Body Mass Index (BMI)[1]
[units: Kilograms/Meters squared]
Mean ± Standard Deviation 		27.28 ± 4.98 28.25 ± 4.90 27.76 ± 4.96
Height  
[units: Centimeters]
Mean ± Standard Deviation 		165.90 ± 9.83 164.70 ± 10.04 165.30 ± 9.94
Weight[2]
[units: kilogram]
Mean ± Standard Deviation 		75.44 ± 17.07 76.98 ± 16.72 76.21 ± 16.89
[1] Body mass index (BMI) is measure of body fat based on height and weight that applies to both adult men and women
[2] Participant Weight in Kilograms



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.   [ Baseline (week 0), Day 1 (post first dose)-12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.   [ Weeks 0, 3, 6, 9, 12, 14, 16 ]
  Show Outcome Measure 2

3.  Secondary:   Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.   [ Weeks 0, 3, 6, 9, 12, 14, 16 ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.   [ Baseline (week 0), Day 1 (post first dose) - Week12 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 5

6.  Secondary:   Mean Subject-reported Sleep Latency Reported at Various Study Time Points.   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 6

7.  Secondary:   Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.   [ Baseline (week 0), Day 1 (post first dose) -week 12 ]
  Show Outcome Measure 7

8.  Secondary:   Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.   [ Baseline (week 0), weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 8

9.  Secondary:   Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 9

10.  Secondary:   Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.   [ Baseline (week 0), Day 1 (post first dose) - Week12 ]
  Show Outcome Measure 10

11.  Secondary:   Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 11

12.  Secondary:   Mean Number of Awakenings (Subject-reported) at Various Study Time Points   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 12

13.  Secondary:   Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - Week12 ]
  Show Outcome Measure 13

14.  Secondary:   Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 14

15.  Secondary:   Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points   [ weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 15

16.  Secondary:   Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 16

17.  Secondary:   Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 17

18.  Secondary:   Mean Subject-reported Depth of Sleep at Various Study Time Points   [ weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 18

19.  Secondary:   Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 19

20.  Secondary:   Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 20

21.  Secondary:   Mean Subject-reported Daytime Alertness at Various Study Time Points.   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 21

22.  Secondary:   Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 22

23.  Secondary:   Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 23

24.  Secondary:   Mean Subject-reported Ability to Function at Various Study Time Points   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 24

25.  Secondary:   Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.   [ Baseliine (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 25

26.  Secondary:   Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 26

27.  Secondary:   Mean Subject-reported Ability to Concentrate at Various Study Time Points   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 27

28.  Secondary:   Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 28

29.  Secondary:   Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 29

30.  Secondary:   Mean Subject-reported Physical Well-Being at Various Study Time Points   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 30

31.  Secondary:   Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose)- week 12 ]
  Show Outcome Measure 31

32.  Secondary:   Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 32

33.  Secondary:   Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 33

34.  Secondary:   Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 34

35.  Secondary:   Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 35

36.  Secondary:   Mean Subject-Reported Total Nap Time at Various Study Time Points   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 36

37.  Secondary:   Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 37

38.  Secondary:   Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 38

39.  Secondary:   Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 39

40.  Secondary:   Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 40

41.  Secondary:   Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points   [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]
  Show Outcome Measure 41

42.  Secondary:   Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points   [ Weeks 0,1,4,7,12,13,15 ]
  Show Outcome Measure 42

43.  Secondary:   Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 43

44.  Secondary:   Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points   [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]
  Show Outcome Measure 44

45.  Secondary:   Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.   [ Weeks 0,1,4,7,12,13,15 ]
  Show Outcome Measure 45

46.  Secondary:   Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 46

47.  Secondary:   Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points   [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]
  Show Outcome Measure 47

48.  Secondary:   Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points   [ weeks 0,1,4,7,12,13,15 ]
  Show Outcome Measure 48

49.  Secondary:   Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Hide Outcome Measure 49

Measure Type Secondary
Measure Title Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
Measure Description Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time Frame Baseline (week 0), Day 1 (post first dose) - week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.

Reporting Groups
  Description
Placebo Placebo tablets
Eszopiclone Eszopiclone 2 mg tablets

Measured Values
  Placebo Eszopiclone
Number of Participants Analyzed
[units: participants] 		62 61
Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
[units: number of awakenings]
Mean ± Standard Deviation 		0.87 ± 3.65 -0.18 ± 4.28


Statistical Analysis 1 for Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.2643
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Multiple comparisons not applied due to only two treatments in the study.



50.  Secondary:   Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.   [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]
  Show Outcome Measure 50

51.  Secondary:   Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points   [ Weeks 0,1,4,7,12,13,15 ]
  Show Outcome Measure 51

52.  Secondary:   Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 52

53.  Secondary:   Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points   [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]
  Show Outcome Measure 53

54.  Secondary:   Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points   [ Week 0,1,4,7,12,13,15 ]
  Show Outcome Measure 54

55.  Secondary:   Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 55

56.  Secondary:   Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points   [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]
  Show Outcome Measure 56

57.  Secondary:   Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.   [ Week 0,1,4,7,12,13,15 ]
  Show Outcome Measure 57

58.  Secondary:   Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 58

59.  Secondary:   Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points   [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]
  Show Outcome Measure 59

60.  Secondary:   Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points   [ Week 0,1,4,7,12,13,15 ]
  Show Outcome Measure 60

61.  Secondary:   Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period   [ Baseline (week 0), Day 1 (post first dose) - week 12 ]
  Show Outcome Measure 61

62.  Secondary:   Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points   [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]
  Show Outcome Measure 62

63.  Secondary:   Mean Insomnia Severity Index Total Scores at Various Study Time Points   [ Weeks 0,3,6,9,12,14,16 ]
  Show Outcome Measure 63

64.  Secondary:   Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale   [ Baseline (week 0), Weeks 6, 12, 16 ]
  Show Outcome Measure 64

65.  Secondary:   Mean Physical Component Summary of the Short Form-36 Scale Scores.   [ Weeks 0,6,12,16 ]
  Show Outcome Measure 65

66.  Secondary:   Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores   [ Baseline (week 0), Weeks 6,12,16 ]
  Show Outcome Measure 66

67.  Secondary:   Mean Mental Component Summary of the Short Form-36 Scale Scores   [ Weeks 0,6,12,16 ]
  Show Outcome Measure 67

68.  Secondary:   Mean Change From Baseline in the Sheehan Disability Scale Total Score.   [ Baseline (week 0), Weeks 6,12,14,16 ]
  Show Outcome Measure 68

69.  Secondary:   Mean Sheehan Disability Total Scores   [ Weeks 0,6,12,14,16 ]
  Show Outcome Measure 69


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The data gathered was subjective (except for actigraphy endpoints) and relied either on self reporting or patient assessments derived from standardized questionnaires.  


Results Point of Contact:  
Name/Title: Lunesta Medical Director
Organization: Sepracor Inc.
phone: 1-866-503-6351


No publications provided


Responsible Party: Sepracor Inc. ( Executive Medical Director, Clinical Research )
Study ID Numbers: 190-904
Study First Received: October 9, 2006
Results First Received: February 13, 2009
Last Updated: June 16, 2009
ClinicalTrials.gov Identifier: NCT00386334     History of Changes
Health Authority: United States: Food and Drug Administration





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