Objective: Evaluate the efficacy of opicapone (OPC) in Parkinson’s disease (PD) patients with motor fluctuations enrolled in the 1-year extension of study BIPARK I.

Background: OPC, a new once-daily COMT inhibitor, was shown to be effective in the treatment of motor fluctuations in Parkinson’s disease patients in two large, pivotal, multinational trials (BIPARK I and II). In BIPARK I, OPC 50 mg significantly reduced OFF-time and increased ON-time without troublesome dyskinesia with a favorable profile compared to entacapone.

Methods: After completing the double-blind (DB) part of the BIPARK I study, 495 patients (placebo n=99, entacapone n=100, OPC 5 mg n=100, OPC 25 mg n=98 and OPC 50 mg n=98) continued to a 1-year open-label (OL) extension, 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 primary efficacy endpoint was the change in OFF-time at end of study treatment based on patient’s diaries. Statistical analysis was performed by a linear mixed-effect model repeated measurement with region as factor and baseline OFF-time as covariate. P-values were calculated post-hoc.

Results: At endpoint, mean OFF-time was decreased by -34 min relative to the start of the OL extension, corresponding to a reduction of more than 2 hours (-127 min) relative to DB baseline. For subjects who received placebo or entacapone in the DB period, the switch to OPC resulted in a statistically significant reduction of OFF-time (-65 min [95% CI: -94, -36; p<.0001] and -39 min [95% CI: -67, -11; p=0.0060], respectively) and increase of ON-time without dyskinesia (43 min [95% CI: 6, 81; p=0.0247] and 46 min [95% CI: 9, 82; p=0.0148], respectively). For subjects previously receiving OPC further improvements upon OFF- and ON-time were observed, but of no statistical significance.

Conclusions: OPC maintained its efficacy over the 1-year treatment period. Switching double-blind entacapone to open-label OPC led to a significant reduction in OFF-time and increase in ON-time without dyskinesia.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/switching-double-blind-opicapone-entacapone-or-placebo-to-open-label-opicapone-efficacy-results-of-the-1-year-extension-of-study-bipark-i/