Objective: To evaluate the impact of opicapone (OPC) on PDQ-39 in levodopa-treated Parkinson’s Disease (PD) patients with ‘early’ motor fluctuations.

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: 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 4-weeks before and throughout the study. ‘Early-fluctuators’ (EF) were defined as subjects with onset of motor fluctuations within <2 years of study baseline. This post-hoc analysis investigated changes in PDQ-39 at the end of double-blind period in OPC-50mg, entacapone (ENT) and placebo (PLC) groups in EF levodopa-treated patients. Data was analyzed via an ANCOVA model with treatment group and region as fixed effects.

Results: In total, 359 patients were randomized; 206 patients were EF (PLC, n=66; ENT, n=70; OPC-50mg, n=70). Overall, LS mean changes from baseline were -2.6 for PLC, -4.0 for ENT and -2.8 for OPC-50mg. Regarding EF, LS mean changes [95%CI] of PDQ-39 from double-blind baseline were -2.0 [-4.4,0.5], -3.3 [-5.7,-0.8] and -3.8 [-6.3,-1.3] for PLC, ENT (p=0.0085) and OPC-50mg (p=0.0026), indicating improvements in health status and quality of life.

Conclusion: Similar to total study population, adding OPC-50mg to ‘early-fluctuators’ improved health status and quality of life. In contrast to PLC and ENT, PQD-39-decreasing was higher in OPC-50mg ‘early fluctuators’ than in the overall population.

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/effect-of-opicapone-in-parkinsons-disease-patients-with-early-motor-fluctuations-parkinsons-disease-questionnaire-pdq-39-analysis-from-the-bipark-i-double-blind/