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Primary InsomniaPhase 3NCT00352144

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

A Phase 3 study testing Eszopiclone in people with Primary Insomnia, run by Sumitomo Pharma America, Inc. at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 64 years
Conditions the study is for
Primary Insomnia
What is being tested?
Eszopiclone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
830 participants
Where
58 sitesUnited States
Study dates
Oct 2003to Oct 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Austin, Texas

  • Study site

    Bala-Cynwyd, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Study site

    Blairsville, Georgia

  • Study site

    Brown Deer, Wisconsin

  • Study site

    Cary, North Carolina

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Elk Grove Village, Illinois

  • Study site

    Eugene, Oregon

  • Study site

    Evansville, Indiana

  • Study site

    Frederick, Maryland

  • Study site

    Hamilton, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Irvine, California

  • Study site

    Jackson, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Jupiter, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, Nebraska

  • Study site

    Longmont, Colorado

  • Study site

    Lubbock, Texas

  • Study site

    Madison, Wisconsin

  • Study site

    Mogadore, Ohio

  • Study site

    Naples, Florida

  • Study site

    New York, New York

  • Study site

    Newton, Massachusetts

  • Study site

    Northbrook, Illinois

  • Study site

    Oakland, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olathe, Kansas

  • Study site

    Orlando, Florida

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Pinellas Park, Florida

  • Study site

    Plano, Texas

  • Study site

    Prairie Village, Kansas

  • Study site

    Pueblo, Colorado

  • Study site

    Redlands, California

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Scottsdale, Arizona

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Tampa, Florida

Other trials in United States

About this study

Official title: A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study

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.

Read the 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.

Being tested
Eszopiclone, Placebo
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EszopicloneDrug

    Also called Lunesta, S-Zopiclone

    Eszopiclone 3 mg

  • PlaceboDrug

    Placebo tablet

Study groups in NCT00352144
Study groupRoleWhat they receive
1Experimentaleszopiclone 3 mg tablet
Receives: Drug: Eszopiclone
2Placebo comparatorPlacebo tablet
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average of Subjective Sleep Latency

    Measured: Days -14, 1, 30, 60, 90, 120, 150, 180

Secondary outcomes (8)

  1. Average of Total Sleep Time (TST) and Wake Time After Sleep Onset (WASO)

    Measured: Days -14, 1, 30, 60, 90, 120, 150, 180

  2. SF-36

    Measured: Days 1, 30, 90, 180

  3. Work Limitations Questionnaire (WLQ)

    Measured: Days 1, 30, 90, 180

  4. Insomnia Severity Index (ISI)

    Measured: Days 1, 30, 90, 180

  5. Fatigue Severity Scale (FSS)

    Measured: Days 1, 30, 90, 180

  6. Epworth Sleepiness Scale (ESS)

    Measured: Days 1, 30, 60, 90, 120, 150, 180

  7. Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)

    Measured: Day 180

  8. Healthcare Utilization Questionnaire (HUQ)

    Measured: Days 1, 30, 60, 90, 120, 150, 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2006 (estimated)
  2. Study startOct 2003
  3. Primary completionOct 2004
  4. Study completionOct 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
830 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352144
Sponsor's protocol ID
190-050
Status last verified
Feb 2012
First submitted
12 Jul 2006
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eszopiclone in people with Primary Insomnia, run by Sumitomo Pharma America, Inc. at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average of Subjective Sleep Latency (time frame: Days -14, 1, 30, 60, 90, 120, 150, 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00352144.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.

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