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

NCT00883740 | Completed Phase 3 Results DMC

• 1 other identifier: A0081165
• Study Type: interventional
• Target: 119
• Locations: 3 countries
• Sites: 50

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)

Conditions

Fibromyalgia; Sleep Disorders

Keywords

Fibromyalgia sleep maintenance disturbance pregabalin

Outcome Measures

Primary Outcomes (1)

• 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 (17)

• Wake Time During Sleep (WTDS)

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

• Wake Time After Sleep (WTAS)

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

• Total Sleep Time (TST)

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

• Sleep Efficiency (SE)

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

• 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

Study Arms (2)

Lyrica

EXPERIMENTAL

flexible dosing Lyrica 300-450mg/day

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pregabalin DRUG

Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day

Lyrica

Placebo DRUG

Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet diagnostic criteria for fibromyalgia;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (50)

Pfizer Investigational Site

Phoenix, Arizona, 85013, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85020, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85741, United States

Location

Pfizer Investigational Site

San Diego, California, 92102, United States

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Colorado Springs, Colorado, 80909, United States

Location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Pfizer Investigational Site

Hallandale, Florida, 33009, United States

Location

Pfizer Investigational Site

Orange City, Florida, 32763, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33026, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

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Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

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Chicago, Illinois, 60634, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

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Pfizer Investigational Site

Crestview Hills, Kentucky, 41017, United States

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Pfizer Investigational Site

Louisville, Kentucky, 40217, United States

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Baton Rouge, Louisiana, 70809, United States

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Hattiesburg, Mississippi, 39401, United States

Location

Pfizer Investigational Site

Hattiesburg, Mississippi, 39402, United States

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Raleigh, North Carolina, 27612, United States

Location

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Beachwood, Ohio, 44122, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44122, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Pfizer Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19139, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29201, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75248, United States

Location

Pfizer Investigational Site

Houston, Texas, 77063, United States

Location

Pfizer Investigational Site

Calgary, Alberta, T2X 3V4, Canada

Location

Pfizer Investigational Site

Edmonton, Alberta, T5R 5W5, Canada

Location

Pfizer Investigational Site

Kelowna, British Columbia, V1Y 3G8, Canada

Location

Pfizer Investigational Site

Kelowna, British Columbia, V1Y 4R9, Canada

Location

Pfizer Investigational Site

Mississauga, Ontario, L5B 4M4, Canada

Location

Pfizer Investigational Site

Point Edward, Ontario, N7V 1X4, Canada

Location

Pfizer Investigational Site

Thornhill, Ontario, L4J 6X2, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M3H 3V6, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M4P 1P2, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M6J 3S3, Canada

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Berlin, 10969, Germany

Location

Pfizer Investigational Site

Berlin, 12683, Germany

Location

Pfizer Investigational Site

Berlin, 13125, Germany

Location

Pfizer Investigational Site

Chemnitz, 09111, Germany

Location

Pfizer Investigational Site

Göppingen, 73033, Germany

Location

Pfizer Investigational Site

Göppingen, 73035, Germany

Location

Pfizer Investigational Site

München, 80336, Germany

Location

Pfizer Investigational Site

München, 81675, Germany

Location

Pfizer Investigational Site

Schwerin, 19053, Germany

Location

Related Publications (1)

• 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.

  PMID: 22232085 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Sleep Wake Disorders

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 25, 2021
• Results First Posted: August 10, 2011

Record last verified: 2011-07

Locations

CA (10); US (30); DE (10)