Preliminary results from a phase III study of pregabalin (Lyrica™) in patients with restless legs syndrome (RLS) suggest that pregabalin may be effective compared with placebo and pramipexole.

The study, A0081186, was a double-blind, 12-month study that randomised more than 700 patients to a placebo, 300mg pregabalin daily or pramipexole, either 0.25 mg/day or 0.5mg daily.

According to the report, patients randomised to pregabalin experienced a significant improvement compared with placebo in RLS symptom severity as measured by the International Restless Leg Group Rating Scale following 12 weeks of treatment. This group also demonstrated an improvement following 12 weeks of treatment in the proportion of patients responding to treatment compared with those on placebo as measured by the Clinical Global Impression Improvement scale.

Furthermore, those treated with pregabalin experienced a reduction in the rate of augmentation (worsening of RLS symptoms that occur after starting a medication to treat RLS) compared with pramipexole 0.5 mg/day over 12 months (no further study details available)..

The report notes that currently Pfizer does not have plans to seek regulatory approval for an indication in RLS. [No further absolute data were available within the Biospace abstract.]