Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia

October 18, 2012 updated by: Sunovion

A Randomized, Double-Blind, Placebo-Controlled and Open-Label Twelve Month Study of the Safety of (S)-Zopiclone in Adult Subjects With Insomnia

A six-month study to determine the safety and efficacy with an additional open-label extension to determine the long-term safety of eszopiclone in the treatment of adult subjects with primary insomnia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A six month, randomized, double-blind and six month open-label extension, multi-center, outpatient study to determine the safety of eszopiclone in the treatment of adult subjects with primary insomnia. Approximately 800 subjects were to be randomized using a 3:1 ratio to receive one of the two treatments, eszopiclone 3 mg or placebo, for 6 months. All subjects completing 6 months of treatment were eligible to receive open-label 3 mg eszopiclone for an additional 6 months. Subjects were allowed to stay on study for up to 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
791

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for primary insomnia and reported 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.
  • Subject was between 21 and 64 years of age (inclusive) at screening. Both males and females were eligible to participate.
  • Subject provided written informed consent indicating that the purpose of the study was understood. The subject was willing to adhere to the regimen and study procedures described in this protocol.
  • Females of childbearing potential must have willingly signed "Women of Child-Bearing Potential Informed Consent" addendum. Females considered not of childbearing potential must have been surgically sterile or greater than one-year post-menopausal, defined as a complete cessation of menstruation for at least one year.
  • Subject's physical examination, including a brief neurological examination, showed no clinically significant abnormal findings at screening.
  • Subject had no known clinically significant abnormal laboratory findings at screening.
  • Subject had no clinically significant Electrocardiography (ECG) abnormalities at screening.

Exclusion Criteria:

  • Subject had 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 had a history of, or current malignancy except for non-melanomatous skin cancer.
  • Subject had objective evidence of active thyroid disease at screening. Subjects on thyroid replacement therapy were included as long as dose had been stable for ≥ 3 months.
  • Subject had a DSM-IV Axis I psychiatric diagnosis other than Sexual and Gender Identity Disorders, or Axis II Personality Disorders (but not schizotypal, schizoid, or borderline personality disorder). Other non-psychotic Axis I disorders except dementia and delirium were considered on a case-by-case basis.
  • Subject had a known sensitivity to racemic zopiclone, any benzodiazepine, any sedative hypnotic, any substance that was contained in the formulation, or had been hospitalized for any allergic conditions (e.g. recurrent dermatitis, drug hypersensitivity, drug allergy, etc.).
  • Subject had difficulties in sleep initiation or maintenance associated with known sleep difficulties (e.g. sleep apnea, restless leg syndrome, (RLS) or periodic leg movement syndrome (PLMS)), or had any condition which had, or may, affect sleep (e.g., chronic pain, Benign prostatic hyperplasia (BPH), etc.).
  • Subject had history of substance abuse in the past 10 years or substance dependence at any time; positive urine drug test at screening.
  • Subject tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result.
  • Subject was known to be seropositive for Human immunodeficiency virus (HIV).
  • Female subjects who were pregnant, lactating or within 6 months post-partum.
  • Subject had a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may have interfered with drug absorption, distribution, metabolism, or excretion.
  • Subject had used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
  • Subject self-reported 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 had taken any psychotropic medications or other medications known to affect sleep within the 3 days prior to screening visit or was anticipated to need any of these types of medications during double-blind treatment.
  • Subject had participated in any investigational study within 30 days prior to screening.
  • Subject had 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.

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
placebo tablet
Drug: placebo
placebo
Experimental: eszopiclone 3 mg
eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).
Drug: eszopiclone 3 mg
eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).
Other Names:
  • lunesta

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Average sleep latency over the last half of the double-blind study period ("last-three-month average" = mean of the monthly averages for months 4, 5, and 6)
Time Frame: Months 4-6
Months 4-6
Occurrence of Adverse Events (AEs) to evaluate the safety of eszopiclone
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Subjective Total sleep time
Time Frame: Months 4-6 average
Months 4-6 average
Subjective Sleep latency
Time Frame: Months 1-3
Months 1-3
Number of awakenings
Time Frame: Months 1-12
Months 1-12
Wake Time After Sleep Onset (WASO)
Time Frame: Months 1-12
Months 1-12
Quality of Sleep
Time Frame: Months 1-12
Months 1-12
AE's
Time Frame: 12 months
12 months
Total sleep time
Time Frame: Months 1-3
Months 1-3

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunovion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lunesta Medical Director, MD, Sunovion

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 190-049

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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