Neupro rotigotine: Phase IV data

The double-blind, German Phase IV ENCORE trial in 66 evaluable patients with idiopathic moderate to severe RLS showed that Neupro met the primary endpoint of a greater reduction in the mean number of nocturnal SBP elevations associated with PLMs from baseline to the end of the 4-week maintenance period vs. placebo (least squares mean treatment difference of 160.3 elevations, p<0.0001). Neupro also met the secondary endpoints of a greater reduction in the mean total number of nocturnal SBP elevations (least squares mean treatment difference of 161.1 elevations, p=0.0028) and mean PLMI score (least squares mean treatment difference of 32.8 points, p<0.0001) vs. placebo. No serious adverse events were reported. The trial enrolled 81 patients to receive placebo or once-daily 1, 2 or 3 mg/24 hour doses of Neupro for 28 days following a titration period. Data were presented at the American Society of Hypertension meeting in San Francisco. ...