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

Phase 3

Completed

Conditions: Sleep Disorders
Fibromyalgia

Interventions: Drug: Placebo
Drug: Pregabalin

Registration Number: NCT00883740

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary: The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 119

Inclusion Criteria

Subjects must meet diagnostic criteria for fibromyalgia;
Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.

Exclusion Criteria

History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
Use of medications known to affect sleep wake function by Visit 2;
Involved in night or rotating shift work, or travel across >4 time zones 14 days prior to screening and during study; regular daytime napping
PSG finding of apnea/hypopnea or periodic limb movement with arousal index >10/hr on either night of PSG.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Lyrica	Pregabalin	flexible dosing Lyrica 300-450mg/day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
Sleep Quality	Weeks 1, 2, 3 and 4 of Each Intervention Period or ET	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.
Daily Pain Score	Daily up to Day 73 or ET	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.
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.
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.
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.
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).
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.
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).
Slow Wave Sleep (SWS)	Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET	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.
Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11	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	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.
Latency of Sleep Onset (LSO)	Weeks 1, 2, 3 and 4 of Each Intervention Period or ET	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.
Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11	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	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.
Subjective Wake After Sleep Onset (sWASO)	Weeks 1, 2, 3 and 4 of Each Intervention Period or ET	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.
Subjective Total Sleep Time (sTST)	Weeks 1, 2, 3 and 4 of Each Intervention Period or ET	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.