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

Phase 3 Completed 119 enrolled Viatris Inc.

RandomizedCrossoverDouble-blindTreatment

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)

Timeline

Start: 2009-06
Primary completion: 2010-06
Completion: 2010-06

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo vs Pregabalin; p <0.0001; Mean Difference (Final Values) -19.15 (95% CI -26.69 to -11.61) NCT00883740 ↗

paper Patients treated with pregabalin showed a reduction in PSG-determined WASO versus treatment with placebo PMID 22232085 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	300 mg	—
Subject	Pregabalin	Small molecule	450 mg	—