Session Information
Date: Thursday, June 23, 2016
Session Title: Parkinson's disease: Clinical trials, pharmacology and treatment
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: Evaluate the efficacy of opicapone (OPC) in fluctuating Parkinson’s disease patients at different stages of symptom progression 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 analysis was performed evaluating the change in OFF-time according to baseline Hoehn and Yahr (HY) stage (<2.5; ≥2.5) and disease duration (<8 years; ≥8 years). OFF-responders were defined as the proportion of patients with ≥ 1 hour reduction of OFF-time.
Results: The analysis set included over 750 subjects (placebo n=255, 25mg-OPC n=241, 50mg-OPC n=262). OPC 50 mg led to significant reductions of OFF-time compared to placebo in all subgroups: -125 min vs. -43 min (p<.0001) for HY<2.5; -111 min vs. -70 min (p=0.0214) for HY ≥2.5; -117 min vs. -54 min (p=0.0001) for disease < 8 years; and -116 min vs. -68 min (p=0.0283) for disease ≥ 8 years. Significant reductions were observed for OPC 25 mg in the HY<2.5 subgroup only (-108 min, p=0.0013). The proportion of OFF responders for OPC 50 mg ranged between 66% for HY≥2.5, 67% for disease < 8 years, and 69% for HY<2.5 and disease ≥ 8 years, with the difference vs. placebo being significant across all subgroups.
Conclusions: OPC 50 mg was associated with significant improvements upon motor fluctuations in patients with short and long disease duration, across mild to more disabling stages of symptom progression.
To cite this abstract in AMA style:
N. Lopes, J. Ferreira, A. Lees, W. Poewe, H. Reichmann, A. Santos, C. Oliveira, J.F. Rocha, P. Soares-da-Silva. Exploratory efficacy of opicapone in fluctuating Parkinson’s disease patients at different stages of symptom progression [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/exploratory-efficacy-of-opicapone-in-fluctuating-parkinsons-disease-patients-at-different-stages-of-symptom-progression/. Accessed September 7, 2024.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/exploratory-efficacy-of-opicapone-in-fluctuating-parkinsons-disease-patients-at-different-stages-of-symptom-progression/