Objective: To evaluate opicapone (OPC) when used in everyday clinical practice conditions to treat Parkinson’s disease (PD) patients with motor fluctuations.
Background: OPC proved to be effective in treating end-of-dose motor fluctuations in PD patients [1,2]. The OPTIPARK study evaluated OPC 50 mg in a heterogeneous population of patients treated in real-world conditions .
Method: OPTIPARK was a prospective, open-label, single-arm, multicentre trial conducted in Germany and the UK. Patients with motor fluctuations received OPC 50 mg in addition to current antiparkinsonian treatment. Primary efficacy endpoint was Clinician’s Global Impression of Change (CGI-C) after 3 months. Secondary efficacy endpoints included Patient’s GI-C (PGI-C) and Unified Parkinson’s Disease Rating Scale (UPDRS). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs). Here Germany-only data are reported.
Results: In total, 363 patients took ≥1 OPC dose (Safety Set; Table 1) and 291 completed the 3-month treatment. Of 349 patients with post-baseline efficacy data (Full Analysis Set), 70.8% and 76.3% experienced any (very much/much/minimal) improvement on CGI-C and PGI-C after 3 months, respectively (Table 2). There were relevant improvements on UPDRS II and III scores (Table 3). TEAEs considered at least possibly related to OPC were reported for 37.7% of patients, the most frequently reported being dyskinesia (5.8%) and dry mouth (4.4%); 91.7% of TEAEs were of mild or moderate intensity. Serious TEAEs considered at least possibly related to OPC were reported for five (1.4%) patients.
Conclusion: OPC 50 mg was effective and generally well tolerated in German 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. 3. Reichmann et al., Transl Neurodegener. 2020;9(1):9
To cite this abstract in AMA style:H. Reichmann, A. Lees, D. Magalhães, J. Rocha, P. Soares-da-Silva. Opicapone in Parkinson’s Disease German Patients with Motor Fluctuations: Findings from the OPTIPARK Study [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/opicapone-in-parkinsons-disease-german-patients-with-motor-fluctuations-findings-from-the-optipark-study/. Accessed December 6, 2023.
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