Trial Outcomes & Findings for Eszopiclone in the Treatment of Insomnia and Fibromyalgia (NCT NCT00392041)

NCT ID: NCT00392041

Last Updated: 2021-01-05

Results Overview

Difference in total sleep time between week 4 and baseline

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

week 4

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Eszopiclone Eszopiclone: 3mg qpm for 12 weeks	Placebo placebo: 1 pill qpm for 12 weeks
First 4 Weeks STARTED	19	17
First 4 Weeks COMPLETED	11	14
First 4 Weeks NOT COMPLETED	8	3
Weeks 5 - 12 STARTED	11	14
Weeks 5 - 12 COMPLETED	7	9
Weeks 5 - 12 NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eszopiclone in the Treatment of Insomnia and Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eszopiclone n=19 Participants Eszopiclone: 3mg qpm for 12 weeks	Placebo n=17 Participants placebo: 1 pill qpm for 12 weeks	Total n=36 Participants Total of all reporting groups
Age, Continuous	41.58 years STANDARD_DEVIATION 8.60 • n=5 Participants	46.94 years STANDARD_DEVIATION 11.14 • n=7 Participants	44.11 years STANDARD_DEVIATION 10.11 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: week 4

Population: 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.

Difference in total sleep time between week 4 and baseline

Outcome measures

Outcome measures
Measure	Eszopiclone n=19 Participants Eszopiclone: 3mg qpm for 12 weeks	Placebo n=17 Participants placebo: 1 pill qpm for 12 weeks
Change in Total Sleep Time (TST) as Recorded in Patient Diaries	68.72 minutes Standard Deviation 69.72	13.47 minutes Standard Deviation 83.21

SECONDARY outcome

Timeframe: week 12

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

Minutes awake after sleep onset as recorded in patient diaries

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 12

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 12

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 12

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

Outcome measures

Outcome data not reported

Adverse Events

Eszopiclone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lesley Allen, Ph.D.

Princeton University

Phone: 609-924-9213

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place