Objective: ON-time evolution following 1-year, open-label (OL), once-daily (QD) opicapone (OPC) treatment in patients with Parkinson’s disease (PD) on levodopa-therapy and with motor fluctuations.

Background: OPC, a new once-daily COMT inhibitor, was shown to be effective in the treatment of motor fluctuations in Parkinson’s disease patients.

Methods: After completion of the placebo- and active-controlled double-blind (DB) part, 495 (91.3%) patients continued to a 1-year OL-part, in which all subjects were treated with OPC (5, 25 or 50-mg OPC). All subjects began with 25-mg OPC QD for 1-week. Then, the investigator freely adjusted the levodopa therapy and/or OPC based on the dopaminergic response and/or associated adverse events. The primary efficacy variable was the change from baseline in OFF-time, based on patient diaries.

Results: Relative to DB baseline, the OFF-time reduction at OL endpoint was above 2 hours in all DB subgroups, with no significant differences between them. As expected, the inverse pattern was seen for the change in ON-time. The largest mean increase from OL baseline was seen for ON-time without dyskinesia for those subjects who had been treated with placebo or entacapone in the DB part. For DB opicapone subgroups, most of the gain in ON-time was ON-time with non-troublesome dyskinesia or without dyskinesia. Importantly, in the opicapone 50-mg, there was a noticeable shift from ON-time with non-troublesome and with troublesome dyskinesia to ON-time without dyskinesia. By-visit analysis showed that increase in ON-time was observed early, with a relevant increase immediately at first OL visit.

Conclusions: Following 1-year use of OPC, ON-time evolution mirrored the OFF-time pattern for which the largest increase observed was ON-time without dyskinesia.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/on-time-evolution-following-one-year-open-label-opicapone-bipark-i-study/