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

Sponsor

Sunovion (Industry)

Overall Status

Completed

CT.gov ID

NCT00366093

Collaborator

(none)

410

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: Eszopiclone Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

410 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

mean subjective SL [Week 1]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Mobile	Alabama	United States
2	San Diego	California	United States
3	Denver	Colorado	United States
4	Newington	Connecticut	United States
5	Aventura	Florida	United States
6	Clearwater	Florida	United States
7	Ft. Meyers	Florida	United States
8	Gainesville	Florida	United States
9	Melbourne	Florida	United States
10	Miami	Florida	United States
11	Naples	Florida	United States
12	New Port Richey	Florida	United States
13	Pembroke Pines	Florida	United States
14	Tampa	Florida	United States
15	West Palm Beach	Florida	United States
16	Atlanta	Georgia	United States
17	Savannah	Georgia	United States
18	Arlington Heights	Illinois	United States
19	Champaign	Illinois	United States
20	Chicago	Illinois	United States
21	Lexington	Kentucky	United States
22	Louisville	Kentucky	United States
23	Boston	Massachusetts	United States
24	Brockton	Massachusetts	United States
25	Ann Arbor	Michigan	United States
26	St. Louis	Missouri	United States
27	Lincoln	Nebraska	United States
28	Reno	Nevada	United States
29	Rochester	New York	United States
30	Cary	North Carolina	United States
31	Raleigh	North Carolina	United States
32	Winston-Salem	North Carolina	United States
33	Cleveland	Ohio	United States
34	Dayton	Ohio	United States
35	Mentor	Ohio	United States
36	Oklahoma City	Oklahoma	United States
37	Medford	Oregon	United States
38	Erie	Pennsylvania	United States
39	Philadelphia	Pennsylvania	United States
40	Pittsburg	Pennsylvania	United States
41	Warwick	Rhode Island	United States
42	Columbia	South Carolina	United States
43	Cordova	Tennessee	United States
44	Houston	Texas	United States
45	Irving	Texas	United States
46	Sandy	Utah	United States
47	Richmond	Virginia	United States
48	Renton	Washington	United States
49	Seatle	Washington	United States
50	Spokane	Washington	United States
51	Tacoma	Washington	United States