Session Time: 1:45pm-3:15pm
Location: Hall 3FG
Objective: To evaluate the impact on non-motor symptoms in levodopa-treated Parkinson’s Disease (PD) patients with ‘early’ motor fluctuations.
Background: Opicapone (OPC), a new once-daily COMT inhibitor, has shown to be effective in the treatment of motor fluctuations in PD patients in two large, pivotal, multinational trials (BIPARK-I and II) [1,2].
Methods: Multinational, multicentre, double-blind, 14 to 15-week, placebo- and active-controlled study. In the emergence of dopaminergic-related adverse events (AE) during the first 3 weeks of treatment, investigators could titrate down the daily dose of levodopa. Dopamine-agonists (DA) and MAO-B inhibitors (MAO-Bi) used for the treatment of PD were also allowed provided their dosage remained stable for at least 4-weeks before and throughout the study . ‘Early fluctuators’ were defined as subjects with an onset of motor fluctuation within <2 years of study baseline that were randomized to OPC-50mg, entacapone (ENT) or placebo (PLC). This post-hoc subgroup analysis investigated the change in Non-motor Symptoms Scale (NMSS) scores at the end of the DB of the OPC-50mg, entacapone (ENT), and placebo (PLC) groups, in levodopa-treated patients with PD and considered as ‘early fluctuators’. Data was analyzed via an ANCOVA model with treatment group and region as fixed effects.
Results: A total of 359 patients were randomized to placebo (PLC, n=121), OPC-50mg (n=116) or ENT (n=122). From these, 206 patients were ‘early fluctuators’ (PLC, n=66), OPC-50mg (n=70) or ENT (n=70). Overall, by the end of the DB period, the post-baseline NMSS total scores decreased in all treatment groups, indicating less disability in non-motor domains. The LS mean changes from DB baseline were -5.7, -4.7 and -2.0 for PLC, ENT and OPC-50mg, respectively. For the ‘early fluctuators’, the LS mean changes [95%CI] from DB baseline were -4.2 [-8.0,-0.3] , -3.0 [-6.7,0.8] and -3.9 [-7.7,-0.1] for PLC, ENT and OPC-50mg, respectively, also indicating less disability in non-motor domains.
Conclusions: Similar to the total study population, the addition of OPC-50 mg to PD patients considered as ‘early fluctuators’ reduced disability in non-motor domains. Of note, in contrast to PLC and ENT, the absolute magnitude of the NMSS decrease was higher in OPC-50mg ‘early fluctuators’ compared to the overall population studied.
References: 1. Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P, et al. Opicapone as an adjunct to levodopa in patients with Parkinson’s disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol 2016;15:154-165. 2. Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, et al. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol 2017;74:197-206.
To cite this abstract in AMA style:A. Antonini, J. Ferreira, W. Poewe, O. Rascol, H. Gama, E. Arbe, J-F. Rocha, P. Soares-da-Silva. Efficacy of opicapone in Parkinson’s disease patients with ‘early’ motor fluctuations: NMSS analysis from the BIPARK-I double-blind experience [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-in-parkinsons-disease-patients-with-early-motor-fluctuations-nmss-analysis-from-the-bipark-i-double-blind-experience/. Accessed December 11, 2023.
« Back to 2018 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-in-parkinsons-disease-patients-with-early-motor-fluctuations-nmss-analysis-from-the-bipark-i-double-blind-experience/