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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00366093
First received: August 17, 2006
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Insomnia
Drug: Eszopiclone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • mean subjective SL [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean subjective WASO [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • Mean subjective SL [ Time Frame: Weeks 2, 3, 4 ] [ Designated as safety issue: No ]
  • Mean subjective WASO [ Time Frame: Weeks 2, 3, 4 ] [ Designated as safety issue: No ]
  • Mean subjective TST [ Time Frame: Weeks 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  • Mean number of awakenings [ Time Frame: Weeks 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  • Sleep quality and depth [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Daytime alertness [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Ability to concentrate [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Physical well-being [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Ability to function [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Mean subjective number of nocturnal awakenings due to hot flashes [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Mean number of hot flashes per day [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Mean number of nocturnal hot flashes per night [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Mean severity of hot flashes [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • ESS score [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
  • ISI score [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
  • GCS score [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
  • SDS score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • MenQOL score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • MADRS score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Physician Global Assessment [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: February 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
eszopiclone 3 mg
Drug: Eszopiclone
eszopiclone 3 mg
Other Names:
  • Lunesta
  • S-zopiclone
Placebo Comparator: 2
Placebo tablet
Drug: Placebo
placebo tablet

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366093

  Show 51 Study Locations
Sponsors and Collaborators
Sunovion
  More Information

No publications provided by Sunovion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00366093     History of Changes
Other Study ID Numbers: 190-054
Study First Received: August 17, 2006
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Menopause
Perimenopause

Additional relevant MeSH terms:
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014