Trial · NCT00883740

Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

NCT00883740, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-08-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia. Trials, record NCT00883740. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00883740

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
NCT number: NCT00883740
Status: Completed
Phases: Phase 3
Enrollment: 119 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Fibromyalgia, Sleep Disorders
Interventions: Pregabalin, Placebo
First posted: 2009-04-20
Last updated: 2021-01-25
Results first posted: 2011-08-10
Limitations and caveats: The protocol specified analyses of secondary outcome measures (OMs) indicated OMs would use PP population; however all secondary OMs were analyzed using the ITT population in accordance with the statistical analysis plan.

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Wake After Sleep Onset (WASO) at Weeks 5 and 11	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)	WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography \[PSG\]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording \[i.e. awake epoch immediately prior to the end of the recording\]) on 2 consecutive nights divided by 2 at the end of each intervention period.
Secondary	Wake Time During Sleep (WTDS)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.
Secondary	Wake Time After Sleep (WTAS)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.
Secondary	Total Sleep Time (TST)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.
Secondary	Sleep Efficiency (SE)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.
Secondary	Number of Awakenings After Sleep Onset (NAASO 1)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period.
Secondary	Number of Awakenings After Sleep Onset (NAASO 2)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.
Secondary	Latency to Persistent Sleep (LPS)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs.
Secondary	WASO by Hour of the Night	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total).
Secondary	WASO by Each Quarter of the Night	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments).

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Wake After Sleep Onset (WASO) at Weeks 5 and 11	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)	Per Protocol Population (PP) = all randomized participants who received study medication at a dose of 300 or 450 mg/day and completed the study without any major protocol violations;	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Wake Time During Sleep (WTDS)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	Intent to treat (ITT) population: randomized participants who received at least one dose of medication and had at least one efficacy evaluation	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Wake Time After Sleep (WTAS)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	ITT	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Total Sleep Time (TST)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	ITT	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Sleep Efficiency (SE)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	ITT	Percentage of time asleep	LEAST_SQUARES_MEAN
SECONDARY	Number of Awakenings After Sleep Onset (NAASO 1)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	ITT	Awakenings	LEAST_SQUARES_MEAN
SECONDARY	Number of Awakenings After Sleep Onset (NAASO 2)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	ITT	Awakenings	LEAST_SQUARES_MEAN
SECONDARY	Latency to Persistent Sleep (LPS)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	ITT	Minutes	LEAST_SQUARES_MEAN
SECONDARY	WASO by Hour of the Night	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	ITT	Minutes	LEAST_SQUARES_MEAN
SECONDARY	WASO by Each Quarter of the Night	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	ITT	Minutes	LEAST_SQUARES_MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group90

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Wake After Sleep Onset (WASO) at Weeks 5 and 11	Placebo	70.69	Standard Error 3.78	Minutes
Wake After Sleep Onset (WASO) at Weeks 5 and 11	Pregabalin	51.54	Standard Error 3.78	Minutes
Wake Time During Sleep (WTDS)	Placebo	63.38	Standard Error 2.90	Minutes
Wake Time During Sleep (WTDS)	Pregabalin	45.83	Standard Error 2.93	Minutes
Wake Time After Sleep (WTAS)	Placebo	9.19	Standard Error 1.55	Minutes
Wake Time After Sleep (WTAS)	Pregabalin	7.38	Standard Error 1.57	Minutes
Total Sleep Time (TST)	Placebo	370.6	Standard Error 4.65	Minutes
Total Sleep Time (TST)	Pregabalin	396.2	Standard Error 4.69	Minutes
Sleep Efficiency (SE)	Placebo	77.21	Standard Error 0.97	Percentage of time asleep
Sleep Efficiency (SE)	Pregabalin	82.64	Standard Error 0.98	Percentage of time asleep

1 to 10 of 90Source ClinicalTrials.gov

See all 90 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	Placebo, Then Pregabalin	60
First Intervention	STARTED	Pregabalin, Then Placebo	59
First Intervention	COMPLETED	Placebo, Then Pregabalin	53
First Intervention	COMPLETED	Pregabalin, Then Placebo	51
First Intervention	NOT COMPLETED	Placebo, Then Pregabalin	7
First Intervention	NOT COMPLETED	Pregabalin, Then Placebo	8
Taper and Washout Period (2 Weeks)	STARTED	Placebo, Then Pregabalin	54
Taper and Washout Period (2 Weeks)	STARTED	Pregabalin, Then Placebo	51
Taper and Washout Period (2 Weeks)	COMPLETED	Placebo, Then Pregabalin	54
Taper and Washout Period (2 Weeks)	COMPLETED	Pregabalin, Then Placebo	51

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	nausea	Gastrointestinal disorders	Placebo	3	111
other	nausea	Gastrointestinal disorders	Pregabalin	8	112
other	dizziness	Nervous system disorders	Placebo	11	111
other	dizziness	Nervous system disorders	Pregabalin	34	112
other	headache	Nervous system disorders	Placebo	9	111
other	headache	Nervous system disorders	Pregabalin	10	112
other	somnolence	Nervous system disorders	Placebo	5	111
other	somnolence	Nervous system disorders	Pregabalin	23	112

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Pregabalin
Total, other adverse events	Placebo	21	111
Total, other adverse events	Pregabalin	51	112
Total, serious adverse events	Placebo	0	111
Total, serious adverse events	Pregabalin	0	112

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22232085	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Pregabalin vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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