Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Su... | NCT00883740

NCT00883740

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Lyrica	Experimental	flexible dosing Lyrica 300-450mg/day	Drug: Pregabalin
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day	Lyrica

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wake After Sleep Onset (WASO) at Weeks 5 and 11	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.	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)

Secondary Outcomes

Measure	Description	Time Frame
Wake Time During Sleep (WTDS)	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.	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Phoenix	Arizona	85013	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22232085	Derived	Roth T, Lankford DA, Bhadra P, Whalen E, Resnick EM. Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. Arthritis Care Res (Hoboken). 2012 Apr;64(4):597-606. doi: 10.1002/acr.21595.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo, Then Pregabalin	Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
FG001	Pregabalin, Then Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Entire Study Population	Includes groups randomized to receive matching placebo and Pregabalin, 75 up to 225 mg, twice per day in the first intervention and Pregabalin, 75 up to 225 mg, and matching placebo twice per day in the second intervention

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00048.4± 9.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000103
Male	BG00016

Medical Outcome Study Sleep Scale (MOS-SS) Sleep Disturbance Baseline Measure (Weeks 1 and 7)

Sleep Disturbance subscale as measured by MOS-SS, a participant rated 12 item instrument. Baseline intervention period 1 collected at week 1 and baseline intervention period 2 collected at week 7. Scores were transformed and ranged from 0 to 100, higher scores indicated greater disturbance, negative changes indicated improvement.

Mean

Standard Deviation

Scores on a Scale

Title

Denominators

Categories

Week 1 Sleep Disturbance Placebo

Title	Measurements
	BG00069.32± 17.48

Week 1 Sleep Disturbance Pregabalin

Title

MOS-SS Overall Sleep Index II Baseline Measure (Weeks 1 and 7)

Overall Sleep Problem Index II determined by a 9 item index that provided a composite measure of overall sleep. Baseline intervention period 1 collected at week 1 and baseline intervention period 2 collected at week 7. Score ranged from 0 to 100, higher scores indicated greater sleep problems, negative changes indicated improvement.

Mean

Standard Deviation

Scores on a Scale

Title

Denominators

Categories

Week 1 Sleep Problems Index II Placebo

Title	Measurements
	BG00062.82± 12.96

Week 1 Sleep Problems Index II Pregabalin

Title	Measurements

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Wake After Sleep Onset (WASO) at Weeks 5 and 11

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.

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;

Posted

Least Squares Mean

Standard Error

Minutes

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG00083 OG00183

Title

Denominators

Categories

Title	Measurements
	OG00070.69± 3.78 OG00151.54± 3.78

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		linear mixed effects model		<0.0001	P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.	Mean Difference (Final Values)	-19.15			2-Sided	95	-26.69	-11.61					Superiority or Other (legacy)

Secondary

Wake Time During Sleep (WTDS)

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.

Intent to treat (ITT) population: randomized participants who received at least one dose of medication and had at least one efficacy evaluation

Posted

Least Squares Mean

Standard Error

Minutes

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants

Secondary

Wake Time After Sleep (WTAS)

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.

ITT

Posted

Least Squares Mean

Standard Error

Minutes

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Total Sleep Time (TST)

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.

ITT

Posted

Least Squares Mean

Standard Error

Minutes

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Sleep Efficiency (SE)

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.

ITT

Posted

Least Squares Mean

Standard Error

Percentage of time asleep

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Number of Awakenings After Sleep Onset (NAASO 1)

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.

ITT

Posted

Least Squares Mean

Standard Error

Awakenings

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Number of Awakenings After Sleep Onset (NAASO 2)

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.

ITT

Posted

Least Squares Mean

Standard Error

Awakenings

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Latency to Persistent Sleep (LPS)

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.

ITT

Posted

Least Squares Mean

Standard Error

Minutes

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

WASO by Hour of the Night

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).

ITT

Posted

Least Squares Mean

Standard Error

Minutes

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants

Secondary

WASO by Each Quarter of the Night

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).

ITT

Posted

Least Squares Mean

Standard Error

Minutes

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants

Secondary

Slow Wave Sleep (SWS)

SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.

ITT

Posted

Least Squares Mean

Standard Error

Percentage of total sleep time

Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11

MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline.

ITT; n: number of participants at specific time points

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Secondary

Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11

MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline.

ITT

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants

Secondary

Sleep Quality

Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores.

ITT; Last observation carried forward (LOCF)

Posted

Least Squares Mean

Standard Error

Unit on a scale

Weeks 1, 2, 3 and 4 of Each Intervention Period or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Latency of Sleep Onset (LSO)

LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant's daily SSQ.

ITT; LOCF

Posted

Least Squares Mean

Standard Error

Minutes

Weeks 1, 2, 3 and 4 of Each Intervention Period or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Daily Pain Score

Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores.

ITT; LOCF

Posted

Least Squares Mean

Standard Error

Units on a scale

Daily up to Day 73 or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Subjective Wake After Sleep Onset (sWASO)

sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant's daily SSQ values.

ITT; LOCF

Posted

Least Squares Mean

Standard Error

Minutes

Weeks 1, 2, 3 and 4 of Each Intervention Period or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Secondary

Subjective Total Sleep Time (sTST)

sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values.

ITT; LOCF

Posted

Least Squares Mean

Standard Error

Minutes

Weeks 1, 2, 3 and 4 of Each Intervention Period or ET

ID	Title	Description
OG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
OG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.			0	111	21	111
EG001	Pregabalin	Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.			0	112	51	112

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
nausea	Gastrointestinal disorders	Meddra v13.0	Systematic Assessment	EG0003 affected111 at risk EG0018 affected112 at risk
dizziness	Nervous system disorders	Meddra v13.0	Systematic Assessment	EG00011 affected111 at risk EG00134 affected112 at risk
headache	Nervous system disorders	Meddra v13.0	Systematic Assessment	EG0009 affected111 at risk EG00110 affected112 at risk
somnolence	Nervous system disorders	Meddra v13.0	Systematic Assessment	EG0005 affected111 at risk EG00123 affected112 at risk

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.

Certain Agreements

ID	Term
D005356	Fibromyalgia
D012893	Sleep Wake Disorders

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

ID	Term
D000069583	Pregabalin

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Units	Counts
Participants	OG000109 OG001108