Clinical trial NCT00883740: Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Sleep Disorders
Keywords: Fibromyalgia sleep maintenance disturbance pregabalin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)


Eligibility 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.

Primary outcomes:
measure: Wake After Sleep Onset (WASO) at Weeks 5 and 11
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)
Secondary outcomes:
measure: Wake Time During Sleep (WTDS)
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: Wake Time After Sleep (WTAS)
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: Total Sleep Time (TST)
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: Sleep Efficiency (SE)
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: Number of Awakenings After Sleep Onset (NAASO 1)
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: Number of Awakenings After Sleep Onset (NAASO 2)
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: Latency to Persistent Sleep (LPS)
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: WASO by Hour of the Night
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: WASO by Each Quarter of the Night
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: Slow Wave Sleep (SWS)
timeFrame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
measure: Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11
timeFrame: 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
measure: Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11
timeFrame: 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
measure: Sleep Quality
timeFrame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
measure: Latency of Sleep Onset (LSO)
timeFrame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
measure: Daily Pain Score
timeFrame: Daily up to Day 73 or ET
measure: Subjective Wake After Sleep Onset (sWASO)
timeFrame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
measure: Subjective Total Sleep Time (sTST)
timeFrame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hallandale Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Hattiesburg
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Hattiesburg
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Point Edward
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Chemnitz
country: Germany
facility: Pfizer Investigational Site
city: Goeppingen
country: Germany
facility: Pfizer Investigational Site
city: Goeppingen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.