Objective: This real-world study evaluated opicapone (OPC) 50-mg in a heterogeneous population of Parkinson’s disease (PD) patients treated in clinical practice.

Background: OPC proved effective in treating end-of-dose motor fluctuations in PD patients in two large multinational trials (BIPARK-I and II) [1,2].

Method: OPTIPARK was a prospective, open-label, single-arm, multicentre trial conducted in Germany and the UK under clinical practice conditions. PD patients with motor fluctuations received OPC 50-mg in addition to current antiparkinsonian treatment. Primary efficacy endpoint was Clinician’s Global Impression of Change (CGIC) after 3 months. Secondary efficacy endpoints included Patient’s GIC (PGIC) and Unified Parkinson’s Disease Rating Scale (UPDRS). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs).

Results: 495 patients took >/=1 OPC dose (Safety Set; Table 1) and 393 completed 3 months’ treatment. Of 477 patients with post-baseline efficacy data (Full Analysis Set), 71.3% and 76.8% experienced very much/much/minimal improvement on CGIC and PGIC after 3 months, respectively (Table 2). There were significant improvements on UPDRS II and III scores (Table 3). TEAEs considered at least possibly related to OPC were reported for 45.1% of patients, the most frequently reported (>/=5% patients) being dyskinesia (11.5%) and dry mouth (6.5%). 94.8% of TEAEs were of mild or moderate intensity. Serious TEAEs considered at least possibly related to OPC were reported for seven (1.4%) patients.

Conclusion: OPC 50-mg was effective and generally well tolerated in PD patients with motor fluctuations treated in clinical practice.

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

« Back to MDS Virtual Congress 2020

MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-in-clinical-practice-in-parkinsons-disease-patients-with-motor-fluctuations-findings-from-the-optipark-study/