6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

NCT ID: NCT00352144

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 830 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2004-10-31

Brief Summary

To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.

Detailed Description

This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled, multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve up to 9 visits and subject participation will be approximately 224 days. After meeting all screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo. 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.

Conditions

Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

eszopiclone 3 mg tablet

Group Type: EXPERIMENTAL

Eszopiclone

Intervention Type: DRUG

Eszopiclone 3 mg

2

Placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet

Interventions

Eszopiclone

Eszopiclone 3 mg

Intervention Type: DRUG

Placebo

Placebo tablet

Intervention Type: DRUG

Other Intervention Names

Lunesta; S-Zopiclone

Eligibility Criteria

Inclusion Criteria

• Subject meets DSM-IV criteria for primary insomnia and reports sleeping no more than 6.5 hours per night and/or taking more than 30 minutes each night to fall asleep for at least one month prior to screening.
• Male and female subjects must be between 21 and 64 years of age, inclusive, at the time of consent.
• Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form. 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.
• Subject must be in general good health, based on screening physical examination (including brief neurological examination), 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 cancer within the past 5 years, or current malignancy except for non melanomatous skin cancer.
• Subject has a psychiatric diagnosis with psychosis, dementia or delirium. Subjects with Sexual and Gender Identity Disorders or other non-psychotic disorders will be considered on a case-by-case basis.
• Subject has one of the following Personality Disorders: schizotypal, schizoid, or borderline personality disorder.
• Subject has difficulties in sleep initiation or maintenance associated with known medical diagnosis (e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS), or has any condition that has or may affect sleep (e.g., chronic pain, BPH, etc.).
• Subject has participated in a previous eszopiclone clinical trial.
• Subject has a known sensitivity to racemic zopiclone, any benzodiazepine, any sedative hypnotic, any substance that is contained in the formulation, or has been hospitalized for any allergic conditions (e.g. recurrent dermatitis, drug hypersensitivity, drug allergy, etc.).
• Subject has history of substance abuse in the past 10 years or substance dependence at any time or positive urine drug test at screening .
• Subject tests positive at screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.
• Subject is known to be seropositive for HIV.
• Female subjects who are pregnant, lactating or within 6 months post partum.
• Subject self-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 has taken any psychotropic medications or other medications known to affect sleep within the 3 days prior to screening visit or is anticipated to need any of these types of medications during double-blind treatment .
• Subject has participated in any investigational study within 30 days prior to screening.
• Subject has taken herbal supplements, purported to have central nervous system effects,(tablets, powders, extracts or tinctures) or combination products with herbs or melatonin within 14 days prior to screening or St. John's Wort within 30 days prior to screening.
• Subject is a rotating or third/night shift worker.
• Subject is a staff member or relative of a staff member.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Anaheim, California, United States

Irvine, California, United States

Oakland, California, United States

Redlands, California, United States

San Diego, California, United States

Aurora, Colorado, United States

Denver, Colorado, United States

Longmont, Colorado, United States

Pueblo, Colorado, United States

Clearwater, Florida, United States

Jacksonville, Florida, United States

Jupiter, Florida, United States

Naples, Florida, United States

Orlando, Florida, United States

Pembroke Pines, Florida, United States

Pinellas Park, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Blairsville, Georgia, United States

Chicago, Illinois, United States

Elk Grove Village, Illinois, United States

Northbrook, Illinois, United States

Evansville, Indiana, United States

Olathe, Kansas, United States

Prairie Village, Kansas, United States

Chevy Chase, Maryland, United States

Frederick, Maryland, United States

Newton, Massachusetts, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Lincoln, Nebraska, United States

Las Vegas, Nevada, United States

Hamilton, New Jersey, United States

New York, New York, United States

Cary, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Mogadore, Ohio, United States

Oklahoma City, Oklahoma, United States

Eugene, Oregon, United States

Bala-Cynwyd, Pennsylvania, United States

Anderson, South Carolina, United States

Columbia, South Carolina, United States

Austin, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Jackson, Texas, United States

Lubbock, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Brown Deer, Wisconsin, United States

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

190-050

Identifier Type: -

Identifier Source: org_study_id