FibromyalgiaPhase 4NCT00392041
Eszopiclone in the Treatment of Insomnia and Fibromyalgia
A Phase 4 study testing Eszopiclone in people with Fibromyalgia and Insomnia, run by Lesley A. Allen, Ph.D. at 1 site in United States.
Trial summary
The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Fibromyalgia, 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
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, age 18 through 64.
- Meets ACR criteria for FMS, as determined by rheumatological examination and a medical history review.
- Reports sleep maintenance insomnia (total sleep time of < 6.5 hours or sleep impairment consisting of 3 of 7 nights per week for a month by history) or sleep onset latency insomnia (at least 3 of 7 nights of sleep latency > 30 minutes), as well as clinically significant daytime distress or impairment during the 1 week self assessment prior to baseline.
- Has completed 8th grade and is fluent in English.
- If a female of child bearing potential, the patient must be non-pregnant and either post-menopausal or using an approved birth control method. Acceptable birth control methods include: history of tubal ligation, having a male partner who is sterile, IUDs, birth control pills or other hormonal birth control methods (e.g., birth control patch, Depo-Provera injections), and double-barrier methods (e.g., condom and foam).
- Antidepressant medication will be allowed if the patient has been on a stable dose for at least one month.
Who cannot join
- Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine-related arthropathy.
- Evidence of a primary sleep disorder (e.g., significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder, or REM sleep behavior disorder.
- Any current, clinically significant medical condition.
- Pregnancy.
- Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain syndrome, or psychoactive substance abuse or dependence.
- Any current psychiatric disorder that would interfere with study participation (investigator judgment).
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- Active suicidal ideation.
- Plans to engage in additional psychotherapy during the study.
- Concurrent use of benzodiazepines after 6pm or as a sleep aid.
- Concurrent use of any other sleep aid.
- Concurrent use of analgesics other than acetaminophen or non-steroidal anti-inflammatory medication.
- Concurrent use of any medication that has not been stabilized for at least 1 month prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
About this study
Official title: Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia
The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
Read the detailed description
Fibromyalgia (FM) is a prevalent, debilitating, and costly syndrome. Although the pathophysiology of FM is not yet well-understood, sleep disturbance is a prominent feature of most theories. Eszopiclone has been approved by the FDA for the treatment of insomnia, but has not been studied in the treatment of FMS. The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia (FMS) in FMS patients. Participants will be randomly selected to receive eszopiclone or placebo. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
- Conditions
- Fibromyalgia, Insomnia
- Being tested
- Eszopiclone, placebo
- Keywords
- Fibromyalgia, Insomnia, Sleep, Eszopiclone, Lunesta
- Medical subject headings
- Fibromyalgia, 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
3mg qpm for 12 weeks
placeboDrug
1 pill qpm for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone | Experimental | Not described Receives: Drug: Eszopiclone |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Sleep Time (TST) as Recorded in Patient Diaries
Difference in total sleep time between week 4 and baseline
Measured: week 4
Secondary outcomes (4)
Wake Time After Sleep Onset (WASO)
Minutes awake after sleep onset as recorded in patient diaries
Measured: week 12
Sleep Quality
Measured: week 12
Clinician-rated Overall Severity of Fibromyalgia
Measured: week 12
Fibromyalgia Impact Questionnaire
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesley A. Allen, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor-investigator, Lesley A. Allen, Ph.D., University of Medicine and Dentistry of New Jersey
- Investigators
- Lesley A. Allen, Ph.D., Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392041
- Sponsor's protocol ID
- 0220060122
- Status last verified
- Dec 2020
- First submitted
- 24 Oct 2006
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00392041
- Acronym / sponsor ID
- 0220060122
- Conditions
- Fibromyalgia, Insomnia
- Keywords
- Fibromyalgia, Insomnia, Sleep, Eszopiclone, Lunesta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lesley A. Allen, Ph.D.University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Aug 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Oct 2006 (estimated)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
Detailed description
Fibromyalgia (FM) is a prevalent, debilitating, and costly syndrome. Although the pathophysiology of FM is not yet well-understood, sleep disturbance is a prominent feature of most theories. Eszopiclone has been approved by the FDA for the treatment of insomnia, but has not been studied in the treatment of FMS. The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia (FMS) in FMS patients. Participants will be randomly selected to receive eszopiclone or placebo. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eszopiclone | Experimental | Drug: Eszopiclone |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, age 18 through 64.
- Meets ACR criteria for FMS, as determined by rheumatological examination and a medical history review.
- Reports sleep maintenance insomnia (total sleep time of < 6.5 hours or sleep impairment consisting of 3 of 7 nights per week for a month by history) or sleep onset latency insomnia (at least 3 of 7 nights of sleep latency > 30 minutes), as well as clinically significant daytime distress or impairment during the 1 week self assessment prior to baseline.
- Has completed 8th grade and is fluent in English.
- If a female of child bearing potential, the patient must be non-pregnant and either post-menopausal or using an approved birth control method. Acceptable birth control methods include: history of tubal ligation, having a male partner who is sterile, IUDs, birth control pills or other hormonal birth control methods (e.g., birth control patch, Depo-Provera injections), and double-barrier methods (e.g., condom and foam).
Key exclusion criteria (12 listed)
- Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine-related arthropathy.
- Evidence of a primary sleep disorder (e.g., significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder, or REM sleep behavior disorder.
- Any current, clinically significant medical condition.
- Pregnancy.
- Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain syndrome, or psychoactive substance abuse or dependence.
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 |
|---|---|---|
| EszopicloneAlso: Lunesta3mg qpm for 12 weeks | Drug | Eszopiclone |
| placebo1 pill qpm for 12 weeks | Drug | Placebo |
Primary outcome
Change in Total Sleep Time (TST) as Recorded in Patient Diaries
Time frame: week 4
Difference in total sleep time between week 4 and baseline
4 secondary outcomes
Wake Time After Sleep Onset (WASO)
Time frame: week 12
Sleep Quality
Time frame: week 12
Clinician-rated Overall Severity of Fibromyalgia
Time frame: week 12
Fibromyalgia Impact Questionnaire
Time frame: week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lesley A. Allen, Ph.D. principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eszopiclone in people with Fibromyalgia and Insomnia, run by Lesley A. Allen, Ph.D. at 1 site 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 6 inclusion and 12 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Total Sleep Time (TST) as Recorded in Patient Diaries (time frame: week 4). 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 5 Jan 2021.