Objective: To investigate efficacy and safety of two doses of Opicapone (OPC) compared to placebo administered once daily for 14 to 15 weeks to Japanese patients with Parkinson’s Disease (PD) presenting with end-of-dose motor fluctuations who were being treated with L-dopa/DCI. To verify the superiority of each OPC treatment compared to the placebo in terms of the primary endpoint, i.e., the change in OFF time from the baseline to the end of treatment period based on the ON/OFF time over 24 hours recorded in a patient diary.

Background: OPC is a long-lasting COMT inhibitor that shows clinically sustained inhibition of COMT activity with once daily dosing. In Japan, OPC is being developed in a small tablet formulation, and this study is the first to investigate the efficacy and safety of OPC tablets in Japanese patients with PD.

Method: This study employed a multicenter, placebo-controlled, randomized, double-blind, parallel-group design and assessed patients with PD presenting with end-of-dose motor fluctuations who were being treated with L-dopa/DCI. A screening period of up to 2 weeks and a subsequent treatment period of 14-15 weeks were utilized, and the treatment period also consisted of an L-dopa dose adjustment period of 2 to 3 weeks followed by an L-dopa fixed dose period of 12 weeks. Subjects were randomized to the placebo, OPC 25 mg, and OPC 50 mg groups at a 1:1:1 ratio. Investigational drugs were administered once daily at bedtime during the treatment period.

Results: A total of 437 patients were randomized to the placebo (n=147), OPC 25 mg (n=145) or OPC 50 mg (n=145) groups. The mean difference in OFF time from baseline to the end of the treatment period from the placebo was -44.68 minutes for the OPC 25 mg group and -37.47 minutes for the OPC 50 mg group, both of which were statistically significant (p=0.0145 and p=0.0392). A higher incidence of adverse events was observed for the OPC groups than the placebo group, but no difference was observed between OPC dose groups.

Conclusion: The administration of both 25 mg and 50 mg OPC tablets once daily in combination with L-dopa/DCI showed good efficacy and safety profiles for Japanese patients with PD presenting with end-of-dose motor fluctuations.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-randomized-placebo-controlled-double-blind-clinical-study-in-japan-of-opicapone-treatment-for-parkinsons-disease-comfort-pd-study-part-1/