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
  Purpose

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)


Condition Intervention Phase
Fibromyalgia
Sleep Disorders
Drug: Pregabalin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects Of Pregabalin On Sleep Maintenance In Subjects With Fibromyalgia Syndrome And Sleep Maintenance Disturbance: A Randomized Placebo-Controlled 2-Way Crossover Polysomnography Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 119
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lyrica
flexible dosing Lyrica 300-450mg/day
Drug: Pregabalin
Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00883740

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Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00883740     History of Changes
Other Study ID Numbers: A0081165
Study First Received: April 17, 2009
Results First Received: May 16, 2011
Last Updated: July 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Fibromyalgia sleep maintenance disturbance pregabalin

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Sleep Disorders
Parasomnias
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014