A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
1 other identifier
interventional
388
1 country
82
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2006
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 9, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
June 2, 2009
CompletedMarch 14, 2016
February 1, 2016
1.3 years
October 9, 2006
February 13, 2009
February 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.
The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
Baseline (week 0), Day 1 (post first dose)-12 weeks
Secondary Outcomes (68)
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
Weeks 0, 3, 6, 9, 12, 14, 16
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Weeks 0, 3, 6, 9, 12, 14, 16
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
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Baseline (week 0), Weeks 3,6,9,12,14,16
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Weeks 0,3,6,9,12,14,16
- +63 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORWeek -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.
Eszopiclone
EXPERIMENTALWeek -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.
Interventions
Eligibility Criteria
You may qualify if:
- Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.
You may not qualify if:
- Subject has recent history of known clinically significant abnormal laboratory findings.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Unknown Facility
Birmingham, Alabama, 35226, United States
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Chandler, Arizona, 85225, United States
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Glendale, Arizona, 85306, United States
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Tucson, Arizona, 85712, United States
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Anaheim, California, 92801, United States
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Irvine, California, 92618, United States
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La Mesa, California, 91942, United States
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Los Angeles, California, 90024, United States
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San Diego, California, 92108, United States
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San Diego, California, 92121, United States
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San Diego, California, 92123, United States
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Colorado Springs, Colorado, 80918, United States
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Denver, Colorado, 80212, United States
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Atlanta, Florida, 30342, United States
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Clearwater, Florida, 33765, United States
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Coral Springs, Florida, 33065, United States
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Delray Beach, Florida, 33458, United States
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Fort Myers, Florida, 33912, United States
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Gables, Florida, 33134, United States
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Jupiter, Florida, 33458, United States
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Maitland, Florida, 32751, United States
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Naples, Florida, 34110, United States
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Orlando, Florida, 32806, United States
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Pembroke Pines, Florida, 33024, United States
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Pinellas Park, Florida, 33781, United States
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Sarasota, Florida, 34238, United States
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St. Petersburg, Florida, 33707, United States
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St. Petersburg, Florida, 33709, United States
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Vero Beach, Florida, 32960, United States
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West Palm Beach, Florida, 33407, United States
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Stockbridge, Georgia, 30281, United States
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Honolulu, Hawaii, 96814, United States
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Chicago, Illinois, 60610, United States
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Chicago, Illinois, 60634, United States
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Vernon Hills, Illinois, 60061, United States
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Evansville, Indiana, 47714, United States
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Overland Park, Kansas, 66212, United States
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Prairie Village, Kansas, 66206, United States
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Crestview Hills, Kentucky, 41017, United States
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Lexington, Kentucky, 40509, United States
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Baton Rouge, Louisiana, 70809, United States
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Baltimore, Maryland, 21208, United States
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Boston, Massachusetts, 02135, United States
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Braintree, Massachusetts, 02184, United States
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Newton, Massachusetts, 02459, United States
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Florissant, Missouri, 63031, United States
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Hamilton, New Jersey, 08690, United States
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Albuquerque, New Mexico, 87106, United States
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Brooklyn, New York, 11235, United States
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Mineola, New York, 11501, United States
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New York, New York, 10021, United States
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New York, New York, 10023, United States
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Rochester, New York, 14609, United States
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Cary, North Carolina, 27540, United States
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Durham, North Carolina, 27710, United States
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Hickory, North Carolina, 28601, United States
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New Bern, North Carolina, 28562, United States
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Winston-Salem, North Carolina, 27157, United States
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Beachwood, Ohio, 44122, United States
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Cincinnati, Ohio, 45206, United States
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Cleveland, Ohio, 44122, United States
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Dayton, Ohio, 45408, United States
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Mogadore, Ohio, 44260, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73112, United States
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Oklahoma City, Oklahoma, 73118, United States
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Allentown, Pennsylvania, 18104, United States
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Duncansville, Pennsylvania, 16635, United States
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Scotland, Pennsylvania, 17254, United States
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Warwick, Rhode Island, 02886, United States
Anderson Pharmaceutical Research
Anderson, South Carolina, 29521, United States
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Anderson, South Carolina, 29621, United States
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Simpsonville, South Carolina, 29681, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77024, United States
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San Antonio, Texas, 78205, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78238, United States
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Wichita Falls, Texas, 76309, United States
Unknown Facility
Fairfax, Virginia, 22030, United States
Unknown Facility
Richmond, Virginia, 23229, United States
Unknown Facility
Spokane, Washington, 99204, United States
Related Publications (1)
Ancoli-Israel S, Krystal AD, McCall WV, Schaefer K, Wilson A, Claus R, Rubens R, Roth T. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. Sleep. 2010 Feb;33(2):225-34. doi: 10.1093/sleep/33.2.225.
PMID: 20175406RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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
- Title
- Lunesta Medical Director
- Organization
- Sepracor Inc.
Study Officials
- STUDY CHAIR
Medical Director, CNS
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2006
First Posted
October 11, 2006
Study Start
October 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
March 14, 2016
Results First Posted
June 2, 2009
Record last verified: 2016-02