Objective: To evaluate the efficacy of opicapone (OPC) in Parkinson’s disease (PD) patients with motor fluctuation according to different levodopa daily intakes.

Background: OPC proved to be effective in treating end-of-dose motor fluctuations (MF) in PD patients [1,2].

Method: Matching OPC 50 mg and placebo (PLC) data from BIPARK-I and II [1, 2] were combined. The studies had similar designs, eligibility criteria and methodologies. Primary efficacy endpoint was change from baseline in absolute OFF-time. Safety was assessed by evaluating the incidence of treatment-emergent adverse events (TEAEs). Subgroup analyses were performed to evaluate consistency and potential trends between subgroups based on different levodopa daily intakes at baseline (Table 1). Efficacy pairwise subgroup analyses were performed using Analysis of Covariance. Safety assessments were analysed descriptively.

Results: Overall, 522 patients were randomised to PLC (n=257) and OPC 50 mg (n=265) (Table 1). OPC 50 mg was significantly more effective than PLC for all subgroup analyses (p<0.05), except for the subgroup of patients treated with ≥6 levodopa daily intakes (p=0.0623; Table 2). Moreover, OPC 50 mg demonstrated enhanced magnitude of effect in patients who had less frequent levodopa intakes (Table 2). There was also a trend towards a lower incidence of dopaminergic-related TEAEs in the same subgroups of patients (Table 3).

Conclusion: These findings indicate that OPC 50 mg is efficacious in the full spectrum of motor fluctuations and could be considered earlier in PD patients.

References: 1. Ferreira JJ, et al. Lancet Neurol. 2016;15:154–65. 2. Lees AJ, et al. JAMA Neurol. 2017;74:197–206.

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