The A0081186 trial is a 12-month randomized double-blind study that enrolled more than 700 patients, who received either a placebo, Lyrica at 300 mg/day, pramipexole at 0.25 mg/day or pramipexole at 0.5 mg/day.
In the study, patients treated with Lyrica showed a significant improvement in RLS symptom severity as measured by the International Restless Leg Group Rating Scale compared with placebo following 12 weeks of treatment.
The Lyrica group also demonstrated an improvement in the proportion of patients responding to treatment as measured by the Clinical Global Impression Improvement scale, and reduced the rate of augmentation compared with pramipexole 0.5 mg/day over 12 months.
The RLS patients treated with Lyrica also reported considerable improvements in the primary endpoint, sleep maintenance, compared to placebo.