Eszopiclone in the Treatment of Insomnia and Fibromyalgia

• Sponsor: Lesley A. Allen, Ph.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT00392041
• Collaborator: Sunovion (Industry)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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 those receiving placebo.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia; Insomnia	Drug: Eszopiclone; Drug: placebo	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eszopiclone	Drug: Eszopiclone; 3mg qpm for 12 weeks; Other Names: Lunesta
Placebo Comparator: Placebo	Drug: placebo; 1 pill qpm for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Change in Total Sleep Time (TST) as Recorded in Patient Diaries [week 4]

   Difference in total sleep time between week 4 and baseline

Secondary Outcome Measures

1. Wake Time After Sleep Onset (WASO) [week 12]

   Minutes awake after sleep onset as recorded in patient diaries

2. Sleep Quality [week 12]

3. Clinician-rated Overall Severity of Fibromyalgia [week 12]

4. Fibromyalgia Impact Questionnaire [week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female, age 18 through 64.

2. Meets ACR criteria for FMS, as determined by rheumatological examination and a medical history review.

3. 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.

4. Has completed 8th grade and is fluent in English.

5. 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).

6. Antidepressant medication will be allowed if the patient has been on a stable dose for at least one month.

Exclusion Criteria:

1. Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine-related arthropathy.

2. 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.

3. Any current, clinically significant medical condition.

4. Pregnancy.

5. Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain syndrome, or psychoactive substance abuse or dependence.

6. Any current psychiatric disorder that would interfere with study participation (investigator judgment).

7. Active suicidal ideation.

8. Plans to engage in additional psychotherapy during the study.

9. Concurrent use of benzodiazepines after 6pm or as a sleep aid.

10. Concurrent use of any other sleep aid.

11. Concurrent use of analgesics other than acetaminophen or non-steroidal anti-inflammatory medication.

12. Concurrent use of any medication that has not been stabilized for at least 1 month prior to screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School	Piscataway	New Jersey	United States	08854

Sponsors and Collaborators

• Lesley A. Allen, Ph.D.
• Sunovion

Investigators

• Principal Investigator: Lesley A. Allen, Ph.D., Rutgers, The State University of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lesley A. Allen, Ph.D., Associate Professor of Psychiatry, University of Medicine and Dentistry of New Jersey
• ClinicalTrials.gov Identifier: NCT00392041
• Other Study ID Numbers: 0220060122
• First Posted: Oct 25, 2006
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Lesley A. Allen, Ph.D., Associate Professor of Psychiatry, University of Medicine and Dentistry of New Jersey: Fibromyalgia; Insomnia; Sleep; Eszopiclone; Lunesta
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Initiation and Maintenance Disorders; Eszopiclone

Study Results

Participant Flow

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	Eszopiclone: 3mg qpm for 12 weeks	placebo: 1 pill qpm for 12 weeks
Period Title: First 4 Weeks
STARTED	19	17
COMPLETED	11	14
NOT COMPLETED	8	3
Period Title: First 4 Weeks
STARTED	11	14
COMPLETED	7	9
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Eszopiclone	Placebo	Total
Arm/Group Description	Eszopiclone: 3mg qpm for 12 weeks	placebo: 1 pill qpm for 12 weeks	Total of all reporting groups
Overall Participants	19	17	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.58 (8.60)	46.94 (11.14)	44.11 (10.11)
Sex: Female, Male (Count of Participants)
Female	19 100%	17 100%	36 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 21.1%	3 17.6%	7 19.4%
Not Hispanic or Latino	15 78.9%	14 82.4%	29 80.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 5.9%	1 2.8%
Asian	0 0%	1 5.9%	1 2.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 21.1%	1 5.9%	5 13.9%
White	15 78.9%	14 82.4%	29 80.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	19 100%	17 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Change in Total Sleep Time (TST) as Recorded in Patient Diaries
Description	Difference in total sleep time between week 4 and baseline
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

Data are reported through week 4, instead of through week 12 as planned, because of the high drop out rate after week 4. Fewer than 50% of participants remained in the study at week 12.

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	Eszopiclone: 3mg qpm for 12 weeks	placebo: 1 pill qpm for 12 weeks
Measure Participants	19	17
Mean (Standard Deviation) [minutes]	68.72 (69.72)	13.47 (83.21)

2. Secondary Outcome

Title	Wake Time After Sleep Onset (WASO)
Description	Minutes awake after sleep onset as recorded in patient diaries
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Data collected was of too poor quality to analyze in a meaningful way

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	Eszopiclone: 3mg qpm for 12 weeks	placebo: 1 pill qpm for 12 weeks
Measure Participants	0	0

3. Secondary Outcome

Title	Sleep Quality
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Data recorded was of too poor quality to analyze in a meaningful way

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	Eszopiclone: 3mg qpm for 12 weeks	placebo: 1 pill qpm for 12 weeks
Measure Participants	0	0

4. Secondary Outcome

Title	Clinician-rated Overall Severity of Fibromyalgia
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Data recorded was of too poor quality to analyze in a meaningful way

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	Eszopiclone: 3mg qpm for 12 weeks	placebo: 1 pill qpm for 12 weeks
Measure Participants	0	0

5. Secondary Outcome

Title	Fibromyalgia Impact Questionnaire
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Data recorded was of too poor quality to analyze in a meaningful way

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	Eszopiclone: 3mg qpm for 12 weeks	placebo: 1 pill qpm for 12 weeks
Measure Participants	0	0

Adverse Events

Time Frame	3 months
Arm/Group Title	Eszopiclone		Placebo
Arm/Group Description	Eszopiclone: 3mg qpm for 12 weeks		placebo: 1 pill qpm for 12 weeks
All Cause Mortality
	Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.