Date: Thursday, June 23, 2016
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: Evaluate the onset and stability of the therapeutic effect of opicapone (OPC) compared to placebo in patients with Parkinson’s disease and motor fluctuations over a 14-15 week treatment period.
Background: OPC is a new once-daily COMT inhibitor shown to be safe and effective in the treatment of motor fluctuations in Parkinson’s disease patients in two large, pivotal, multinational trials (BIPARK I and II).
Methods: Data of matching treatment arms of BIPARK I and II studies was combined (placebo, 25mg-OPC and 50mg-OPC). The studies had similar designs and measurement instruments. In both studies the primary efficacy endpoint was the change from baseline to end of study treatment in absolute OFF-time based on patient’s diaries. An exploratory post hoc analysis was performed evaluating the change in OFF- and different ON-time states from baseline at each study visit (week 1, week 2-3, week 6-7, week 10-11, week 14-15). Statistical analysis was performed by a mixed model for repeated measurements with study and geographical area as factors and baseline as covariate.
Results: The analysis set included over 750 subjects (placebo n=255, 25mg-OPC n=241, 50mg-OPC n=262). Statistically significant differences between either 25mg- or 50mg-OPC and placebo were observed at all post-baseline timepoints for OFF- and ON-time without troublesome dyskinesia. At first post-baseline assessment (week 1), mean OFF-time was significantly decreased by 61 min for 25mg-OPC and 75 min for 50mg-OPC vs. 23 min for placebo (p=0.0013, p<0.0001; respectively). Further improvements were reached at week 2-3, after which treatment effect stabilized. At study endpoint (week 14-15), mean OFF-time was significantly decreased by 93 min for 25mg-OPC and 120 min for 50mg-OPC vs. 55 min for placebo (p=0.0091, p<0.0001; respectively).
Conclusions: OPC was associated with significant improvements upon motor fluctuations already at first week of treatment, attaining maximum and stable benefits within two to three weeks of treatment onset.
To cite this abstract in AMA style:A. Lees, J. Ferreira, H. Reichmann, E. Tolosa, A. Santos, C. Oliveira, I. Oliveira, N. Lopes, J.F. Rocha, P. Soares-da-Silva. Onset and stabilization of opicapone treatment effects in fluctuating Parkinson’s disease patients: Exploratory by-week efficacy analysis of pooled phase III studies [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/onset-and-stabilization-of-opicapone-treatment-effects-in-fluctuating-parkinsons-disease-patients-exploratory-by-week-efficacy-analysis-of-pooled-phase-iii-studies/. Accessed September 23, 2023.
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