Primary InsomniaPhase 3NCT01710631
Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia
A Phase 3 study testing eszopiclone 3 mg in people with Primary Insomnia, run by Sumitomo Pharma America, Inc..
Trial summary
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. 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 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 791 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Aug 2002
- 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 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.
Who cannot join
- 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.).
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- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Insomnia
- Being tested
- eszopiclone 3 mg, placebo
- Keywords
- Sleep
- 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.
eszopiclone 3 mgDrug
Also called lunesta
eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| eszopiclone 3 mg | Experimental | eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet). Receives: Drug: eszopiclone 3 mg |
| placebo | Placebo comparator | placebo tablet Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Months 4-6
Occurrence of Adverse Events (AEs) to evaluate the safety of eszopiclone
Measured: 12 Months
Secondary outcomes (7)
Subjective Total sleep time
Measured: Months 4-6 average
Subjective Sleep latency
Measured: Months 1-3
Number of awakenings
Measured: Months 1-12
Wake Time After Sleep Onset (WASO)
Measured: Months 1-12
Quality of Sleep
Measured: Months 1-12
AE's
Measured: 12 months
Total sleep time
Measured: Months 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startFeb 2001
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 791 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lunesta Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710631
- Sponsor's protocol ID
- 190-049
- Status last verified
- Oct 2012
- First submitted
- 17 Oct 2012
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled and Open-Label Twelve Month Study of the Safety of (S)-Zopiclone in Adult Subjects With Insomnia
- ClinicalTrials.gov ID
- NCT01710631
- Acronym / sponsor ID
- 190-049
- Conditions
- Primary Insomnia
- Keywords
- Sleep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 791 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eszopiclone 3 mg | Experimental | Drug: eszopiclone 3 mgeszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet). |
| placebo | Placebo comparator | Drug: placeboplacebo tablet |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eszopiclone 3 mgAlso: lunestaeszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet). | Drug | eszopiclone 3 mg |
| placeboplacebo | Drug | placebo |
Primary outcome
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
Occurrence of Adverse Events (AEs) to evaluate the safety of eszopiclone
Time frame: 12 Months
7 secondary outcomes
Subjective Total sleep time
Time frame: Months 4-6 average
Subjective Sleep latency
Time frame: Months 1-3
Number of awakenings
Time frame: Months 1-12
Wake Time After Sleep Onset (WASO)
Time frame: Months 1-12
Quality of Sleep
Time frame: Months 1-12
AE's
Time frame: 12 months
Total sleep time
Time frame: Months 1-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lunesta Medical Director, MD study director
Sumitomo Pharma America, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eszopiclone 3 mg in people with Primary Insomnia, run by Sumitomo Pharma America, Inc..
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 7 inclusion and 16 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 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2012.