To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.
Primary Outcome Measures:
- Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. [ Time Frame: Baseline (week 0), Day 1 (post first dose)-12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean Change From Baseline in Subject-Reported Total Sleep Time at Various Study Time Points. [ Time Frame: Weeks 0, 3, 6, 9, 12, 14, 16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Total Sleep Time in Minutes at Various Study Time Points. [ Time Frame: Weeks 0, 3, 6, 9, 12, 14, 16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period. [ Time Frame: Baseline (week 0), Day 1 (post first dose) - Week12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Sleep Latency at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Sleep Latency Reported at Various Study Time Points. [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-Blind Study Period. [ Time Frame: Baseline (week 0), Day 1 (post first dose) -week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. [ Time Frame: Baseline (week 0), weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Wake Time After Sleep Onset (WASO) at Various Study Time Points [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period. [ Time Frame: Baseline (week 0), Day 1 (post first dose) - Week12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in the Number of Subject-Reported Awakenings at Various Study Time Points. [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Number of Awakenings (Subject-Reported) at Various Study Time Points [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - Week12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Quality of Sleep at Various Study Time Points. [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Ratings of Subject-Reported Quality of Sleep at Various Study Time Points [ Time Frame: weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-Blind Period. [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Depth of Sleep at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Depth of Sleep at Various Study Time Points [ Time Frame: weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change in Subject-Reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Daytime Alertness at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Daytime Alertness at Various Study Time Points. [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Ability to Function at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Ability to Function at Various Study Time Points [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period. [ Time Frame: Baseliine (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Ability to Concentrate at Various Study Time Points. [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Ability to Concentrate at Various Study Time Points [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Physical Well-Being at Various Study Time Points. [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Physical Well-Being at Various Study Time Points [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose)- week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Total Nap Time at Various Study Time Points [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points [ Time Frame: Weeks 0,1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. [ Time Frame: Weeks 0,1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points [ Time Frame: weeks 0,1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. [ Time Frame: Baseline (week 0), Weeks 1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points [ Time Frame: Weeks 0,1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points [ Time Frame: Week 0,1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. [ Time Frame: Week 0,1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Baseline (week 0), Weeks 1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points [ Time Frame: Week 0,1,4,7,12,13,15 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period [ Time Frame: Baseline (week 0), Day 1 (post first dose) - week 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points [ Time Frame: Baseline (week 0), Weeks 3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Insomnia Severity Index Total Scores at Various Study Time Points [ Time Frame: Weeks 0,3,6,9,12,14,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale [ Time Frame: Baseline (week 0), Weeks 6, 12, 16 ] [ Designated as safety issue: No ]
- Mean Physical Component Summary of the Short Form-36 Scale Scores. [ Time Frame: Weeks 0,6,12,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores [ Time Frame: Baseline (week 0), Weeks 6,12,16 ] [ Designated as safety issue: No ]
- Mean Mental Component Summary of the Short Form-36 Scale Scores [ Time Frame: Weeks 0,6,12,16 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in the Sheehan Disability Scale Total Score. [ Time Frame: Baseline (week 0), Weeks 6,12,14,16 ] [ Designated as safety issue: No ]
- Mean Sheehan Disability Total Scores [ Time Frame: Weeks 0,6,12,14,16 ] [ Designated as safety issue: No ]
| Enrollment: |
388 |
| Study Start Date: |
October 2006 |
| Study Completion Date: |
February 2008 |
| Primary Completion Date: |
February 2008 (Final data collection date for primary outcome measure) |
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Placebo: Placebo Comparator
Week -2 to day 0 single blind one tablet placebo in the evening. Double blind period: Day 1 to Week 12 double blind one tablet placebo in the evening. Follow up period: two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.
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Drug: Placebo
Tablet one per day in the evening.
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Eszopiclone: Experimental
Week -2 to day 0 single blind one tablet placebo in evening. Double Blind period: Day 1 to Week 12 double blind one tablet 2 mg of eszopiclone in evening. Follow up period consists of two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.
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Drug: Eszopiclone
2 mg tablet once per day in the evening
Drug: Placebo
Tablet one per day in the evening.
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A double-blind, randomized, placebo controlled, parallel group study of eszopiclone in elderly subjects with primary chronic insomnia. The study will involve up to 9 visits and subject participation will be approximately 18 weeks.
Purpose
Show 81 Study Locations
