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

Background: OPC, a novel 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. The primary efficacy variable was the change from baseline in absolute OFF-time based on patient diaries [1]. ‘Early fluctuators’ were defined as subjects with an onset of motor fluctuation within <2 years of study baseline. This post-hoc subgroup analysis investigated the efficacy of OPC-50mg compared with entacapone (ENT) and placebo (PLC), in levodopa-treated patients with PD and considered as ‘early fluctuators’

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, both OPC-50mg and ENT significantly reduced the OFF-time (-116.8 min [p=0.0015] OPC-50mg and -96.3 min [p=0.014] ENT vs. -56 min placebo) and increased the ON-time without troublesome dyskinesia (+109.1 min [p=0.002] OPC-50mg and +94.1 min [p=0.02] ENT vs. +46.5 min PLC). For the ‘early fluctuators’, OPC-50mg significantly reduced the OFF-time (-117.6 min [p=0.0033] when compared to placebo (-44.8 min). ENT reduced non-significantly the OFF-time by -91.2 min [p=0.061]. The ON-time without troublesome dyskinesia was significantly increased by +111.8 min [p=0.0006] OPC-50mg and +95.5 min [p=0.0052] ENT when compared to +25.6 min PLC.

Conclusions: Similar to the total study population, OPC-50 mg was effective in reducing motor fluctuations in patients considered ‘early fluctuators’ resulting in a similar and significant reduction in OFF-time and increase in ON-time.

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.

« Back to 2018 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-in-parkinsons-disease-patients-with-early-motor-fluctuations-the-bipark-i-double-blind-experience/