Efficacy of opicapone at different levodopa regimens up to a threshold of 600 mg/day levodopa in Parkinson's disease patients with motor fluctuations

Document Type

Conference Proceeding

Publication Date

10-1-2021

Publication Title

J Neurol Sci

Abstract

Background and aims: Opicapone (OPC) proved to be effective for end-of-dose motor fluctuations in Parkinson's disease (PD) patients. We evaluated the efficacy of OPC in PD patients with motor fluctuations being treated with different levodopa regimens up to a threshold of 600 mg/day levodopa. Methods: Efficacy data from BIPARK-I and II were combined for the placebo (PLC) and OPC-50 mg groups. Primary efficacy endpoint was change from baseline in OFF-time. Subgroup analyses were performed to evaluate the efficacy of OPC-50 mg in different levodopa regimens up to a threshold of 600 mg/day levodopa (300–400, 400–500 and 500–600 mg/day). Results: Full Analysis Set included 239 patients (PLC, n = 118; OPC-50 mg, n = 121). Mean OFF-time reduction was at least two-fold greater than PLC when OPC-50 mg was added to any levodopa regimen: mean (95% confidence interval) changes from baseline in absolute OFF-time for OPC-50 mg versus PLC were − 102.2 (−138.1, −66.3) versus −53.4 (−89.6, −17.3) min for patients treated with levodopa 300–400 mg/day, −110.0 (−146.7, −73.3) versus −37.2 (−77.7, 3.3) min for patients treated with levodopa 400–500 mg/day, and − 117.6 (−152.6, −82.6) versus −23.1 (−67.8, 21.6) min for patients treated with levodopa 500–600 mg/day. It was notable that, with increasing levodopa dose regimens, there was a trend towards decreasing magnitude of effect in the PLC group, compared with a trend towards a slight increase in magnitude of effect in the OPC-50 mg group (Fig. 1). Conclusions: OPC-50 mg showed at least a two-fold greater OFF-time reduction than placebo, with a slight increase in magnitude of effect with increasing levodopa regimens.

PubMed ID

Not assigned.

Volume

429

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