Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)

Sponsor

Sunovion (Industry)

Overall Status

Completed

CT.gov ID

NCT00685269

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Syndrome	Drug: Eszopiclone Drug: Placebo	Phase 2

Detailed Description

Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. This study will compare the use of eszopiclone to placebo for subjects with mild to moderate obstructive sleep Apnea syndrome (OSAS). Frequency and duration of apnea and hypopnea episodes, oxygen saturation, objective sleep parameters and safety information will be collected in this study. 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 :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Jan 1, 2004

Actual Study Completion Date :

Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A eszopiclone 3 mg QD	Drug: Eszopiclone Eszopiclone 3 mg QD Other Names: Lunesta (S)-Zopliclone
Placebo Comparator: B placebo tablet	Drug: Placebo Placebo tablet

Arm

Intervention/Treatment

Active Comparator: A

eszopiclone 3 mg QD

Drug: Eszopiclone

Eszopiclone 3 mg QD

Other Names:

Lunesta

(S)-Zopliclone

Placebo Comparator: B

placebo tablet

Drug: Placebo

Placebo tablet

Outcome Measures

Primary Outcome Measures

AHI (frequency of apnea and hypopnea episodes). [Nights -14, 1, 2, 8, 9]

Secondary Outcome Measures

The mean duration of apnea and hypopnea episodes [Nights -14, 1, 2, 8, 9]
Oxygen saturation during apnea and hypopnea [Nights -14, 1, 2, 8, 9]
The number of arousals during apnea and hypopnea [Nights -14, 1, 2, 8, 9]
Objective sleep parameters as measured by PSG (i.e., latency to persistent sleep, sleep efficiency, and wake time after sleep onset [Nights -14, 1, 2, 8, 9]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The subject is capable of understanding and complying with the protocol and has signed the informed consent document, including the privacy authorization. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form.
Male and female subjects between 35 and 64 years of age, inclusive, with mild to moderate obstructive sleep apnea syndrome (AHI range ≥10 and ≤40).
Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
Subjects must use continuous positive airway pressure (CPAP).
Subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).

Exclusion Criteria:

Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
Subject has a history of, or current malignancy except for non melanomatous skin cancer.
Subject tests positive at screening for hepatitis B surface antigen or hepatitis C antibody, or the subject has a history of a positive result.
Subject is known to be seropositive for human immunodeficiency virus (HIV).