(HealthDay)—For patients with Parkinson's disease (PD) receiving levodopa therapy and experiencing end-of-dose motor fluctuations, treatment with 50-mg/day opicapone is associated with a reduction in mean daily off-time, according to a study published online Dec. 27 in JAMA Neurology.
Andrew J. Lees, M.D., from University College London, and colleagues enrolled 427 patients with PD receiving levodopa therapy who experienced signs of end-of-dose deterioration into a phase 3 trial. Participants were randomized to a 14- to 15-week placebo-controlled trial (129 received 25-mg/day opicapone, 154 received 50-mg/day opicapone, and 144 received placebo). Of the 376 patients who completed the double-blind phase, 286 completed a one-year open-label phase in which all patients received opicapone.
The researchers found that the least squares mean change in off-time was −64.5 minutes for the placebo group, and −101.7 and −118.8 minutes for the 25- and 50-mg/day opicapone groups, respectively. For the 50-mg/day opicapone group, the adjusted treatment difference versus placebo was significant (−54.3 minutes; P = 0.008); the difference was not significant for the 25-mg group (−37.2 minutes; P = 0.11). Throughout the open-label phase, the off-time reduction was sustained (−126.3 minutes at one-year end point).
"Treatment with a 50-mg once-daily dose of opicapone was associated with a significant reduction in mean daily off-time in levodopa-treated patients with PD and motor fluctuations, and this effect is maintained for at least one year," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including BIAL, which manufactures opicapone and funded the study.
Journal information: Archives of Neurology
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