A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia - Full Text View

Sponsor:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00386334

Purpose

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.

Condition	Intervention	Phase
Insomnia	Drug: Eszopiclone Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia

Resource links provided by NLM:

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Sepracor, Inc.:

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)

Arms	Assigned Interventions
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.	Drug: Placebo Tablet one per day in the evening.
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.	Drug: Eszopiclone 2 mg tablet once per day in the evening Drug: Placebo Tablet one per day in the evening.

Detailed Description:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386334

Hide Study Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35226
United States, Arizona

Glendale, Arizona, United States, 85306

Tucson, Arizona, United States, 85712

Chandler, Arizona, United States, 85225
United States, California

Irvine, California, United States, 92618

San Diego, California, United States, 92123

La Mesa, California, United States, 91942

San Diego, California, United States, 92108

Anaheim, California, United States, 92801

San Diego, California, United States, 92121

Los Angeles, California, United States, 90024
United States, Colorado

Denver, Colorado, United States, 80212

Colorado Springs, Colorado, United States, 80918
United States, Florida

Orlando, Florida, United States, 32806

Delray Beach, Florida, United States, 33458

Naples, Florida, United States, 34110

Coral Springs, Florida, United States, 33065

Pembroke Pines, Florida, United States, 33024

Jupiter, Florida, United States, 33458

Gables, Florida, United States, 33134

Ft. Myers, Florida, United States, 33912

Maitland, Florida, United States, 32751

Sarasota, Florida, United States, 34238

West Palm Beach, Florida, United States, 33407

Clearwater, Florida, United States, 33765

Vero Beach, Florida, United States, 32960

Pinellas Park, Florida, United States, 33781

Atlanta, Florida, United States, 30342

St. Petersburg, Florida, United States, 33709

St. Petersburg, Florida, United States, 33707
United States, Georgia

Stockbridge, Georgia, United States, 30281
United States, Hawaii

Honolulu, Hawaii, United States, 96814
United States, Illinois

Chicago, Illinois, United States, 60610

Vernon Hills, Illinois, United States, 60061

Chicago, Illinois, United States, 60634
United States, Indiana

Evansville, Indiana, United States, 47714
United States, Kansas

Prairie Village, Kansas, United States, 66206

Overland Park, Kansas, United States, 66212
United States, Kentucky

Crestview Hills, Kentucky, United States, 41017

Lexington, Kentucky, United States, 40509
United States, Louisiana

Baton Rouge, Louisiana, United States, 70809
United States, Maryland

Baltimore, Maryland, United States, 21208
United States, Massachusetts

Braintree, Massachusetts, United States, 02184

Newton, Massachusetts, United States, 02459

Boston, Massachusetts, United States, 02135
United States, Missouri

Florissant, Missouri, United States, 63031
United States, New Jersey

Hamilton, New Jersey, United States, 08690
United States, New Mexico

Albuquerque, New Mexico, United States, 87106
United States, New York

Rochester, New York, United States, 14609

New York, New York, United States, 10023

Brooklyn, New York, United States, 11235

New York, New York, United States, 10021

Mineola, New York, United States, 11501
United States, North Carolina

Cary, North Carolina, United States, 27540

Durham, North Carolina, United States, 27710

Hickory, North Carolina, United States, 28601

Winston-Salem, North Carolina, United States, 27157

New Bern, North Carolina, United States, 28562
United States, Ohio

Cleveland, Ohio, United States, 44122

Cincinnati, Ohio, United States, 45206

Mogadore, Ohio, United States, 44260

Beachwood, Ohio, United States, 44122

Dayton, Ohio, United States, 45408
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73103

Oklahoma City, Oklahoma, United States, 73112

Oklahoma City, Oklahoma, United States, 73118
United States, Pennsylvania

Scotland, Pennsylvania, United States, 17254

Allentown, Pennsylvania, United States, 18104

Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island

Warwick, Rhode Island, United States, 02886
United States, South Carolina

Simpsonville, South Carolina, United States, 29681

Anderson, South Carolina, United States, 29621
United States, Texas

Houston, Texas, United States, 77024

San Antonio, Texas, United States, 78205

San Antonio, Texas, United States, 78229

San Antonio, Texas, United States, 78238

Wichita Falls, Texas, United States, 76309

Dallas, Texas, United States, 75231
United States, Virginia

Richmond, Virginia, United States, 23229

Fairfax, Virginia, United States, 22030
United States, Washington

Spokane, Washington, United States, 99204

Sponsors and Collaborators

Sepracor, Inc.

Investigators

Study Chair:

Medical Director, CNS

Sepracor, Inc.

Ages Eligible for Study:	65 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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