NCT00883740

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

Effects Of Pregabalin On Sleep Maintenance In Subjects With Fibromyalgia Syndrome And Sleep Maintenance Disturbance: A Randomized Placebo-Controlled 2-Way Crossover Polysomnography Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Pregabalin	Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day
DRUG	Placebo	Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-04-20
• Last updated: 2021-01-25
• Results posted: 2011-08-10

Locations

50 sites across 3 countries: United States, Canada, Germany