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

Last updated: January 21, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

3

Condition

Fibromyalgia

Sleep Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00883740
A0081165
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomniacriteria 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 priorto screening and during study; regular daytime napping
  • PSG finding of apnea/hypopnea or periodic limb movement with arousal index >10/hr oneither night of PSG.

Study Design

Total Participants: 119
Study Start date:
June 01, 2009
Estimated Completion Date:
June 30, 2010

Connect with a study center

  • Pfizer Investigational Site

    Calgary, Alberta T2X 3V4
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Edmonton, Alberta T5R 5W5
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Kelowna, British Columbia V1Y 4R9
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Mississauga, Ontario L5B 4M4
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Point Edward, Ontario N7V 1X4
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Thornhill, Ontario L4J 6X2
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Toronto, Ontario M3H 3V6
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Berlin, 12683
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Chemnitz, 09111
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Goeppingen, 73033
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Muenchen, 80336
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Schwerin, 19053
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Pfizer Investigational Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Pfizer Investigational Site

    San Diego, California 92102
    United States

    Site Not Available

  • Pfizer Investigational Site

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Pfizer Investigational Site

    DeLand, Florida 32720
    United States

    Site Not Available

  • Pfizer Investigational Site

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Pfizer Investigational Site

    Orange City, Florida 32763
    United States

    Site Not Available

  • Pfizer Investigational Site

    Pembroke Pines, Florida 33026
    United States

    Site Not Available

  • Pfizer Investigational Site

    South Miami, Florida 33143
    United States

    Site Not Available

  • Pfizer Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Pfizer Investigational Site

    Chicago, Illinois 60634
    United States

    Site Not Available

  • Pfizer Investigational Site

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Pfizer Investigational Site

    Crestview Hills, Kentucky 41017
    United States

    Site Not Available

  • Pfizer Investigational Site

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Pfizer Investigational Site

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Pfizer Investigational Site

    Hattiesburg, Mississippi 39402
    United States

    Site Not Available

  • Pfizer Investigational Site

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Pfizer Investigational Site

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Pfizer Investigational Site

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Pfizer Investigational Site

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Pfizer Investigational Site

    Dallas, Texas 75248
    United States

    Site Not Available

  • Pfizer Investigational Site

    Houston, Texas 77063
    United States

    Site Not Available

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