Objective: To evaluate, in levodopa-treated Parkinson’s Disease (PD) patients with ‘early’ motor fluctuations, the patients’ and clinicians’ perception of PD symptoms improvement [as assessed by Patient and Clinical Global Impression of Change (PGI-C and CGI-C)].

Background: Opicapone (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: Double-blind, 14 to 15-week, placebo- and active-controlled study [1]. Dopamine-agonists and MAO-B inhibitors used for PD treatment were allowed provided their stable regimen for at least 4-weeks before and throughout the study. ‘Early-fluctuators’ (EF) were defined as subjects with an onset of motor fluctuation within <2 years of study baseline. This post-hoc analysis investigated both PGI-C and CGI-C in levodopa-treated EF.

Results: In total, 359 patients were randomized (placebo (PLC), n=121; entacapone (ENT), n=122; OPC-50mg, n=116); 206 patients were EF (PLC, n=66; ENT, n=70; OPC-50mg, n=70). Table 1 describes CGI-C and PGI-C improvement (comprising minimally, much, and very much improved) at endpoint in overall population and EF. In contrast to OPC, no differences were noted for ENT compared with PLC in both total and EF population [table1].

Conclusion: Similar to total study population, the ‘early-fluctuators’ patients’ and clinicians’ perception of improvement was significant for opicapone in comparison to placebo or entacapone in this post-hoc analysis.

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/efficacy-of-opicapone-in-parkinsons-disease-patients-with-early-motor-fluctuations-patient-and-clinical-global-impression-of-change-from-the-bipark-i-double-blind-experienc/