Objective: To evaluate, in levodopa-treated Parkinson’s Disease (PD) patients, the ability of opicapone (OPC) to act as levodopa-sparing agent.

Background: OPC, a once-daily COMT inhibitor, proved effective in the treatment of motor fluctuations in PD patients in two large, pivotal, multinational trials (BIPARK-I and II) [1],[2].

Method: Patient-level double-blind data from matching treatment arms in BIPARK-I and II were combined for the OPC-50mg group. The studies had similar designs (primary efficacy endpoint: change from baseline in patient diaries-based absolute OFF-time) and eligibility criteria [1],[2]. An exploratory post-hoc analysis was performed to evaluate motor response (OFF- and ON-time change and UPDRS III) and quality of life (assessed by PDQ-39) in levodopa-treated PD patients that reduced levodopa.

Results: From the 517 Full Analysis Set patients, 262 were randomized to OPC-50mg and 41 (16%) had a daily levodopa reduction during the double-blind adjustment period. Mean levodopa dose at baseline was ~840 mg and patients presented ~6.5 hours of mean OFF-time. By the end of adjustment period, levodopa was reduced, on average, by ~23% (~200mg) either due to dopaminergic adverse-events (n=30) or proactively (n=11, 27%). Despite dose reduction, levodopa-reduced patients had an absolute mean OFF-time decrease and ON-time increase of >2hours (-131mins and +125mins, respectively) by the end of double-blind period. Additionally, UPDRS parts II and III and PDQ-39 improved from baseline by -2, -3 and -3 points, respectively.

Conclusion: Findings suggest that opicapone could act as levodopa-sparing agent and still improve both quality of life and motor response of levodopa-treated PD patients.

References: [1] Ferreira et al., Lancet Neurology 2016; 15(2):154-165. [2] Lees et al., JAMA Neurol. 2017; 74(2):197-206.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-as-a-levodopa-sparing-agent-pooled-analysis-of-bipark-i-and-ii-double-blind-trials/