Phase 4
N=388
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00386334 ↗Enrolled (actual)
388
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. — 33.18; 63.24 minutes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Eszopiclone (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. |
33.18; 63.24 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. |
20.65; 51.02; 32.47; 61.91; 38.73; 69.00 | — |
| SECONDARY Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. |
294.03; 297.86; 314.53; 347.37; 326.25; 358.72 | — |
| SECONDARY Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period. |
-19.92; -24.62 | 0.0014 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points |
-13.34; -21.89; -19.69; -24.13; -23.02; -24.21 | — |
| SECONDARY Mean Subject-reported Sleep Latency Reported at Various Study Time Points. |
82.17; 75.68; 68.80; 54.69; 62.57; 52.11 | — |
| SECONDARY Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period. |
-14.75; -36.40 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. |
-8.55; -29.26; -13.46; -36.57; -17.67; -40.32 | — |
| SECONDARY Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points |
90.86; 92.66; 83.17; 64.33; 77.86; 56.49 | — |
| SECONDARY Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period. |
-0.27; -0.56 | 0.0005 sig |
| SECONDARY Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. |
-0.16; -0.46; -0.24; -0.56; -0.33; -0.57 | — |
| SECONDARY Mean Number of Awakenings (Subject-reported) at Various Study Time Points |
1.95; 2.10; 1.78; 1.66; 1.72; 1.55 | — |
| SECONDARY Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period |
0.68; 1.39 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. |
0.37; 1.12; 0.62; 1.35; 0.81; 1.52 | — |
| SECONDARY Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points |
4.84; 4.68; 5.22; 5.77; 5.48; 6.01 | — |
| SECONDARY Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period. |
0.69; 1.33 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points |
0.40; 1.07; 0.62; 1.30; 0.82; 1.46 | — |
| SECONDARY Mean Subject-reported Depth of Sleep at Various Study Time Points |
4.87; 4.72; 5.29; 5.76; 5.51; 6.00 | — |
| SECONDARY Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period |
0.61; 1.02 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points |
0.39; 0.76; 0.55; 0.99; 0.72; 1.10 | — |
| SECONDARY Mean Subject-reported Daytime Alertness at Various Study Time Points. |
5.34; 5.42; 5.74; 6.18; 5.89; 6.41 | — |
| SECONDARY Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period |
0.53; 0.91 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points |
0.36; 0.69; 0.46; 0.87; 0.62; 0.98 | — |
| SECONDARY Mean Subject-reported Ability to Function at Various Study Time Points |
5.62; 5.69; 5.98; 6.38; 6.09; 6.57 | — |
| SECONDARY Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period. |
0.50; 0.96 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. |
0.32; 0.73; 0.43; 0.93; 0.60; 1.03 | — |
| SECONDARY Mean Subject-reported Ability to Concentrate at Various Study Time Points |
5.66; 5.63; 5.99; 6.37; 6.10; 6.57 | — |
| SECONDARY Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period |
0.52; 0.87 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. |
0.35; 0.68; 0.46; 0.84; 0.61; 0.93 | — |
| SECONDARY Mean Subject-reported Physical Well-Being at Various Study Time Points |
5.45; 5.62; 5.80; 6.30; 5.92; 6.46 | — |
| SECONDARY Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period |
-0.78; -1.23 | 0.1175 |
| SECONDARY Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points |
-0.39; -1.15; -0.80; -1.26; -0.96; -1.33 | — |
| SECONDARY Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. |
4.03; 3.88; 3.67; 2.76; 3.26; 2.64 | — |
| SECONDARY Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period |
-36.02; -60.06 | 0.0717 |
| SECONDARY Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. |
-21.66; -59.06; -40.02; -65.99; -40.25; -56.59 | — |
| SECONDARY Mean Subject-Reported Total Nap Time at Various Study Time Points |
189.31; 171.62; 169.24; 114.43; 150.88; 106.99 | — |
| 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 |
-2.44; -2.98 | 0.1182 |
| 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 |
-1.78; -2.77; -2.52; -3.16; -2.72; -2.94 | — |
| SECONDARY Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points |
9.05; 7.02; 7.35; 4.33; 6.61; 3.91 | — |
| SECONDARY Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period |
14.40; 17.96 | 0.3010 |
| SECONDARY Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points |
3.72; 14.97; 17.21; 16.89; 15.72; 22.12 | — |
| SECONDARY Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points |
351.06; 367.95; 354.11; 381.52; 366.69; 382.39 | — |
| SECONDARY Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period |
0.00; 1.47 | 0.7800 |
| SECONDARY Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points |
9.06; -0.25; -2.16; -1.48; 0.12; -1.62 | — |
| SECONDARY Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. |
31.34; 23.89; 37.74; 26.72; 28.55; 26.62 | — |
| SECONDARY Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period |
4.50; -4.24 | 0.0803 |
| SECONDARY Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points |
3.17; -6.59; 4.67; -3.88; 6.57; -4.19 | — |
| SECONDARY Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points |
60.27; 63.75; 63.53; 55.39; 64.16; 58.86 | — |
| SECONDARY Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period |
0.87; -0.18 | 0.2643 |
| SECONDARY Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. |
0.76; -0.54; 0.79; 0.04; 0.88; -0.21 | — |
| SECONDARY Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points |
21.49; 22.84; 22.42; 21.86; 22.28; 22.51 | — |
| SECONDARY Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period |
1.61; -2.67 | 0.0765 |
| SECONDARY Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points |
1.33; -0.62; 1.02; -3.43; 1.68; -2.83 | — |
| SECONDARY Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points |
20.52; 22.33; 20.94; 21.69; 20.63; 18.90 | — |
| SECONDARY Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period |
21.26; -40.91 | 0.2967 |
| SECONDARY Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points |
2.37; 6.56; 6.37; -56.87; 23.03; -31.85 | — |
| SECONDARY Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. |
418.49; 438.02; 399.19; 445.84; 403.18; 381.15 | — |
| 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. |
0.45; -1.75 | 0.0634 |
| 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 |
1.38; -0.17; -0.56; -2.14; 0.18; -1.75 | — |
| SECONDARY Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points |
15.12; 14.05; 16.29; 13.89; 14.35; 11.92 | — |
| SECONDARY Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period |
-3.42; -5.67 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points |
-2.74; -4.94; -3.35; -5.67; -3.55; -5.89 | — |
| SECONDARY Mean Insomnia Severity Index Total Scores at Various Study Time Points |
16.34; 16.12; 13.52; 11.09; 12.87; 10.40 | — |
| SECONDARY Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale |
1.01; 1.00; 1.38; 1.01; 0.69; 0.39 | — |
| SECONDARY Mean Physical Component Summary of the Short Form-36 Scale Scores. |
43.99; 45.39; 45.06; 46.08; 45.38; 46.12 | — |
| SECONDARY Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores |
-0.44; 0.96; -0.94; 0.83; -1.22; 0.20 | — |
| SECONDARY Mean Mental Component Summary of the Short Form-36 Scale Scores |
49.69; 49.29; 49.49; 49.96; 48.98; 49.86 | — |
| SECONDARY Mean Change From Baseline in the Sheehan Disability Scale Total Score. |
-2.60; -4.05; -3.73; -4.48; -3.11; -3.52 | — |
| SECONDARY Mean Sheehan Disability Total Scores |
11.38; 11.13; 8.87; 7.52; 7.70; 7.08 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.
Exclusion Criteria
- Subject has recent history of known clinically significant abnormal laboratory findings.
Data sourced from ClinicalTrials.gov (NCT00386334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.