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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00883740
First received: April 17, 2009
Last updated: July 14, 2011
Last verified: July 2011

April 17, 2009
July 14, 2011
June 2009
June 2010   (final data collection date for primary outcome measure)
Wake After Sleep Onset (WASO) at Weeks 5 and 11 [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET) ] [ Designated as safety issue: No ]
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.
Mean WASO (Wake After Sleep Onset) from two consecutive nights in the last visit of each treatment period [ Time Frame: Baseline, end of Week 4, End of Week 9 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00883740 on ClinicalTrials.gov Archive Site
  • Wake Time During Sleep (WTDS) [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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.
  • Wake Time After Sleep (WTAS) [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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.
  • Total Sleep Time (TST) [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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.
  • Sleep Efficiency (SE) [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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.
  • Number of Awakenings After Sleep Onset (NAASO 1) [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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.
  • Number of Awakenings After Sleep Onset (NAASO 2) [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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.
  • Latency to Persistent Sleep (LPS) [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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).
  • WASO by Each Quarter of the Night [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.
  • Sleep Quality [ Time Frame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET ] [ Designated as safety issue: No ]
    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.
  • Latency of Sleep Onset (LSO) [ Time Frame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET ] [ Designated as safety issue: No ]
    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.
  • Daily Pain Score [ Time Frame: Daily up to Day 73 or ET ] [ Designated as safety issue: No ]
    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.
  • Subjective Wake After Sleep Onset (sWASO) [ Time Frame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET ] [ Designated as safety issue: No ]
    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) [ Time Frame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET ] [ Designated as safety issue: No ]
    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.
  • MOS-SS subscales and overall Sleep Problem Index [ Time Frame: Weeks -2, 0, 4, 6, 9 ] [ Designated as safety issue: No ]
  • subject rated Total Sleep Time and WASO [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Adverse Events, including Serious Adverse Events [ Time Frame: All Study Visits and Telephone Contacts and Spontaneous ] [ Designated as safety issue: Yes ]
  • PSG Endpoints ( total sleep time, sleep efficiency, number of awakening after sleep, WASO by hour and quarter of the night, wake time during slep, wake time after sleep, slow wave sleep) [ Time Frame: Baseline, end of Week 4, End of Week 9 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
Effects Of Pregabalin On Sleep Maintenance In Subjects With Fibromyalgia Syndrome And Sleep Maintenance Disturbance: A Randomized Placebo-Controlled 2-Way Crossover Polysomnography Study

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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Fibromyalgia
  • Sleep Disorders
  • Drug: Pregabalin
    Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day
  • Drug: Placebo
    Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks
  • Experimental: Lyrica
    flexible dosing Lyrica 300-450mg/day
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany
 
NCT00883740
A0081165
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP