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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

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.