Date: Thursday, June 23, 2016
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: Evaluate the proportion of patients with Parkinson’s disease and motor fluctuations responding to opicapone (OPC) or placebo treatment 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 proportion of responders in each treatment group at different cut-offs, namely ≥1h, ≥2h, ≥3h, ≥30%, ≥40% and ≥50% improvement from baseline for OFF- and total ON-time. Statistical analysis was performed by a pairwise Cochran-Mantel-Haenszel test stratified by study.
Results: The analysis set included over 750 subjects (placebo n=255, 25mg-OPC n=241, 50mg-OPC n=262). The proportion of OFF-time responders for 50mg-OPC was significantly higher than placebo for all cut-offs: 67.6% vs. 49.0% (≥1h), 47.7% vs. 32.2% (≥2h), 32.4% vs. 18.8% (≥3h), 48.1% vs. 32.5% (≥30%), 38.5% vs. 23.5% (≥40%) and 29.4% vs. 20.4% (≥50%); p<0.05 for all comparisons. For 25mg-OPC, statistical differences compared to placebo were found only at lower cut-offs (≥1h, ≥30% and ≥40%). Results for ON-time were overall similar.
Conclusions: OPC 50 mg once-daily was associated with significant improvements upon motor fluctuations across a range of responses considered clinically meaningful.
To cite this abstract in AMA style:A. Lees, J. Ferreira, T. Müller, F. Stocchi, C. Oliveira, A. Santos, N. Lopes, J.F. Rocha, P. Soares-da-Silva. Opicapone in fluctuating Parkinson’s disease patients: OFF- and ON-time responder post-hoc analyses of pooled phase III studies [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/opicapone-in-fluctuating-parkinsons-disease-patients-off-and-on-time-responder-post-hoc-analyses-of-pooled-phase-iii-studies/. Accessed September 25, 2023.
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