Clinical trial NCT00386334: A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
Official title: A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Keywords: insomnia
chronic
primary
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 388
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

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.

Primary outcomes:
measure: Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.
timeFrame: Baseline (week 0), Day 1 (post first dose)-12 weeks
Secondary outcomes:
measure: Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
timeFrame: Weeks 0, 3, 6, 9, 12, 14, 16
measure: Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
timeFrame: Weeks 0, 3, 6, 9, 12, 14, 16
measure: Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.
timeFrame: Baseline (week 0), Day 1 (post first dose) - Week12
measure: Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.
timeFrame: Baseline (week 0), Day 1 (post first dose) -week 12
measure: Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
timeFrame: Baseline (week 0), weeks 3,6,9,12,14,16
measure: Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.
timeFrame: Baseline (week 0), Day 1 (post first dose) - Week12
measure: Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Number of Awakenings (Subject-reported) at Various Study Time Points
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - Week12
measure: Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
timeFrame: weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-reported Depth of Sleep at Various Study Time Points
timeFrame: weeks 0,3,6,9,12,14,16
measure: Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-reported Daytime Alertness at Various Study Time Points.
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-reported Ability to Function at Various Study Time Points
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.
timeFrame: Baseliine (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-reported Ability to Concentrate at Various Study Time Points
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-reported Physical Well-Being at Various Study Time Points
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose)- week 12
measure: Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-Reported Total Nap Time at Various Study Time Points
timeFrame: Weeks 0,3,6,9,12,14,16
measure: 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
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 1,4,7,12,13,15
measure: Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
timeFrame: Weeks 0,1,4,7,12,13,15
measure: Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 1,4,7,12,13,15
measure: Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
timeFrame: Weeks 0,1,4,7,12,13,15
measure: Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 1,4,7,12,13,15
measure: Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
timeFrame: weeks 0,1,4,7,12,13,15
measure: Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
timeFrame: Baseline (week 0), Weeks 1,4,7,12,13,15
measure: Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
timeFrame: Weeks 0,1,4,7,12,13,15
measure: Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 1,4,7,12,13,15
measure: Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
timeFrame: Week 0,1,4,7,12,13,15
measure: Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 1,4,7,12,13,15
measure: Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
timeFrame: Week 0,1,4,7,12,13,15
measure: 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.
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: 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
timeFrame: Baseline (week 0), Weeks 1,4,7,12,13,15
measure: Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
timeFrame: Week 0,1,4,7,12,13,15
measure: Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period
timeFrame: Baseline (week 0), Day 1 (post first dose) - week 12
measure: Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
timeFrame: Baseline (week 0), Weeks 3,6,9,12,14,16
measure: Mean Insomnia Severity Index Total Scores at Various Study Time Points
timeFrame: Weeks 0,3,6,9,12,14,16
measure: Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale
timeFrame: Baseline (week 0), Weeks 6, 12, 16
measure: Mean Physical Component Summary of the Short Form-36 Scale Scores.
timeFrame: Weeks 0,6,12,16
measure: Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores
timeFrame: Baseline (week 0), Weeks 6,12,16
measure: Mean Mental Component Summary of the Short Form-36 Scale Scores
timeFrame: Weeks 0,6,12,16
measure: Mean Change From Baseline in the Sheehan Disability Scale Total Score.
timeFrame: Baseline (week 0), Weeks 6,12,14,16
measure: Mean Sheehan Disability Total Scores
timeFrame: Weeks 0,6,12,14,16
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Atlanta
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Ft. Myers
country: United States
state: Florida
city: Gables
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Vernon Hills
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Prairie Village
country: United States
state: Kansas
city: Crestview Hills
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Braintree
country: United States
state: Massachusetts
city: Newton
country: United States
state: Massachusetts
city: Florissant
country: United States
state: Missouri
city: Hamilton
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Scotland
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
facility: Anderson Pharmaceutical Research
state: South Carolina
city: Anderson
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, CNS
role: STUDY_CHAIR
References:
citation: 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.