Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause

February 21, 2012 updated by: Sunovion

The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause

To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of eszopiclone 3 mg in women with insomnia secondary to perimenopause or menopause. Eligible subjects will be randomized to either eszopiclone 3 mg or placebo nightly for four 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.

Study Type

Interventional

Enrollment (Actual)

410

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
    • California
      • San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Newington, Connecticut, United States
    • Florida
      • Aventura, Florida, United States
      • Clearwater, Florida, United States
      • Ft. Meyers, Florida, United States
      • Gainesville, Florida, United States
      • Melbourne, Florida, United States
      • Miami, Florida, United States
      • Naples, Florida, United States
      • New Port Richey, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Savannah, Georgia, United States
    • Illinois
      • Arlington Heights, Illinois, United States
      • Champaign, Illinois, United States
      • Chicago, Illinois, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Brockton, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Reno, Nevada, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Cary, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Dayton, Ohio, United States
      • Mentor, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Erie, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburg, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Cordova, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Irving, Texas, United States
    • Utah
      • Sandy, Utah, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Renton, Washington, United States
      • Seatle, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • Subject must understand the purpose of the study and be willing to adhere to the study schedule and procedures described in this protocol.
  • Subject must be between the ages of 40 and 60 years, inclusive, on the day of signing consent.
  • Subject must have perimenopausal or menopausal signs and symptoms.
  • Subject must report SL of >45 minutes and <6 hours of TST at least three times a week over the previous month and symptoms of insomnia must post date onset of perimenopausal or menopausal symptoms.
  • Subject's physical exam must show no clinically significant abnormal findings (other than insomnia and menopause symptoms) at screening.

Exclusion Criteria

  • Subject has history of circadian rhythm disorder, or travels across >3 time zones on a regular basis.
  • Female subject is pregnant, lactating or within 6-months post partum.
  • Subject has a history of drug or alcohol abuse or dependence in the past 2 years or positive urine drug test at screening .
  • Subject has unstable medical abnormality, or unstable chronic disease; or history of significant cardiac, renal, or hepatic disease, seizure disorder, or current or past acute suicidal tendencies.
  • Subject has participated in any investigational drug study within 30 days prior to screening or plans to participate in another investigational drug study during participation in this study.
  • Subject is taking hormone replacement therapy or an hormonal contraceptive, and has not been on a stable dose for a minimum of 60 days prior to study start.
  • Subject is known to be seropositive for HIV.
  • Subject has a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption distribution, metabolism, or excretion.
  • Subject has a history of malignancy within 5 years, or current malignancy, except for non-melanoma skin cancer.
  • Subject has a diagnosis of any psychiatric disorder as identified by a psychiatric screening questionnaire.
  • Subject has any primary diagnosis (personality disorder or mental retardation) that would impact the investigator's ability to evaluate the safety or efficacy of the study medication.
  • Subject has difficulties in sleep initiation or maintenance associated with other known primary sleep disorders [e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS)], or has any condition that may affect sleep (e.g., chronic pain, urinary incontinence, etc.).
  • Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
  • Subject reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.
  • Subject is a rotating or third/night shift worker.
  • Subject is a staff member or relative of a staff member.
  • Subject is experiencing symptoms of premature menopause or surgical menopause.
  • Subject has discontinued hormone replacement therapy or a hormonal contraceptive, and has not been off treatment for a minimum of 60 days prior to study start.
  • Subject has been on hormone replacement therapy or hormonal contraceptives for greater then one year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
eszopiclone 3 mg
Drug: Eszopiclone
eszopiclone 3 mg
Other Names:
  • Lunesta
  • S-zopiclone
Placebo Comparator: 2
Placebo tablet
Drug: Placebo
placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean subjective SL
Time Frame: Week 1
Week 1

Secondary Outcome Measures

Outcome Measure
Time Frame
mean subjective WASO
Time Frame: Week 1
Week 1
Mean subjective SL
Time Frame: Weeks 2, 3, 4
Weeks 2, 3, 4
Mean subjective WASO
Time Frame: Weeks 2, 3, 4
Weeks 2, 3, 4
Mean subjective TST
Time Frame: Weeks 1, 2, 3, 4
Weeks 1, 2, 3, 4
Mean number of awakenings
Time Frame: Weeks 1, 2, 3, 4
Weeks 1, 2, 3, 4
Sleep quality and depth
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Daytime alertness
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Ability to concentrate
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Physical well-being
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Ability to function
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Mean subjective number of nocturnal awakenings due to hot flashes
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Mean number of hot flashes per day
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Mean number of nocturnal hot flashes per night
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Mean severity of hot flashes
Time Frame: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
ESS score
Time Frame: Weeks 2 and 4
Weeks 2 and 4
ISI score
Time Frame: Weeks 2 and 4
Weeks 2 and 4
GCS score
Time Frame: Weeks 2 and 4
Weeks 2 and 4
SDS score
Time Frame: Week 4
Week 4
MenQOL score
Time Frame: Week 4
Week 4
MADRS score
Time Frame: Week 4
Week 4
Physician Global Assessment
Time Frame: Week 4
Week 4
withdrawal effects will be assessed for the ISI, ESS, MADRS, MenQOL, Greene Climacteric Scale, Sheehan Disability Scale, and Physician Global Assessment.
Time Frame: Week 5
Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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