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Effects of Pregabalin (Lyrica) on Sleep Maintenance in Subjects With Fibromyalgia - NCT00883740-75230(Clinical Trial 419650)



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City:  Dallas
State:  
TX
Zip Code: 75230
Conditions: Fibromyalgia - Sleep Disorders
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)
Study summary:
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.
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Data Source: ClinicalTrials.gov
Date Processed: April 13, 2010
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