Phase 3 Study of Lyrica for Restless Legs Syndrome
Pfizer announced results from its Phase 3 study of Lyrica (pregabalin) for the treatment of restless legs syndrome (RLS). The study was a randomized, double-blind, 12-month trial involving more than 700 patients who received either a placebo, Lyrica 300mg/day, pramipexole 0.25mg/day or pramipexole 0.5mg/day.
After 12 weeks of treatment, patients treated with Lyrica experienced statistically significant improvement compared with placebo in RLS symptom severity as measured by the International Restless Leg Group Rating Scale. In the Lyrica group, there was also a statistically significant improvement in the proportion of patients responding to treatment compared with those on placebo as measured by the Clinical Global Impression Improvement scale. In addition, Lyrica treatment resulted in a statistically significant reduction in the rate of augmentation (worsening of RLS symptoms that occur after starting a medication to treat RLS) compared with pramipexole 0.5mg/day over 12 months.
Lyrica is an alpha2-delta ligand and a schedule C-V controlled substance currently approved for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy in partial onset seizures, and fibromyalgia.
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