Objective: Evaluate the effects of opicapone (OPC) on the activities of daily living and motor scores of the UPDRS in fluctuating Parkinson’s disease patients.

Background: BIPARK I was a multinational, 14-15 week, double-blind (DB), randomized, placebo- and entacapone-controlled study followed by a 1-year open-label (OL) extension to investigate the effect of opicapone in fluctuating Parkinson’s disease patients. The UPDRS was employed as a secondary outcome. Here we report the results of the UPDRS activities of daily living (II) and motor (III) scores at DB and OL endpoints.

Methods: A total of 600 patients was randomized in a 1:1:1:1:1 ratio to 5mg-, 25mg-, 50mg-OPC, placebo or entacapone. Those completing the DB period could continue to an OL extension (n=495), in which all subjects were to receive flexible doses of OPC (25-mg OPC QD for 1-week; then investigator could freely adjust the levodopa therapy and/or OPC [5, 25 or 50-mg] according to clinical response). The UPDRS was assessed by certified raters during ON-time (II and VI also at OFF). At DB endpoint (14-15 weeks), treatment differences were analyzed by a linear mixed model with baseline, region and treatment as fixed effects. At OL endpoint (1-year after switch to OPC flexible), treatment differences were evaluated by a two-sample t-test (post-hoc).

Results: At DB endpoint the UPDRS II and III scores improved similarly for the 3 OPC doses and entacapone [UPDRS II (ON) -1.5, -1.9, -1.6, -1.5; UPDRS II (OFF) -2.8, -3.1, -3.0, 3.1; UPDRS III -5.5, -5.0, -4.5, -4.4 for 5mg-, 25mg-, 50mg-OPC, entacapone respectively], however no statistically significant differences were found compared to placebo, except for 5mg-OPC in UPDRS III (p=0.0497). Further improvements were observed during the subsequent 1-year OL OPC treatment. At OL endpoint the UPDRS II (ON) was improved relative to baseline by -2.2, the UPDRS II (OFF) by -4.4 and the UPDRS III by -7.4, the difference being statistically significant compared to prior placebo for UPDRS II (OFF) and UPDRS III (p=0.0043; p=0.0456, respectively).

Conclusions: The use of OPC in fluctuating Parkinson’s disease patients was associated with improvements that persisted after 1-year of treatment upon the activities of daily living and motor scores of the UPDRS.

« Back to 2016 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/activities-of-daily-living-and-motor-scores-of-the-updrs-in-fluctuating-parkinsons-disease-patients-treated-with-opicapone/