%0 Journal Article
%@ 1351-5101
%A Ferreira, JJ
%A Lees, A
%A Rocha, J-F
%A Poewe, W
%A Rascol, O
%A Soares-da-Silva, P
%D 2019
%F discovery:10067664
%J European Journal of Neurology
%K Opicapone,  Parkinson's disease, motor fluctuations, OFF time
%N 7
%P 953-960
%T Long‐term efficacy of opicapone in fluctuating Parkinson's disease patients: a pooled analysis of data from two phase 3 clinical trials and their open‐label extensions
%U https://discovery.ucl.ac.uk/id/eprint/10067664/
%V 26
%X BACKGROUND: We aimed to evaluate the efficacy of the catechol-O-methyltransferase (COMT) inhibitor, opicapone (25 and 50mg), as adjunct therapy to levodopa in a pooled population of Parkinson's disease patients who participated in the pivotal double-blind trials of opicapone and their 1-year open-label extensions. METHODS: Data (placebo, opicapone 25mg and opicapone 50mg) from the BIPARK 1 and 2 double-blind and open-label studies were combined. The studies had similar designs, eligibility criteria and assessment methods. The primary efficacy variable in both double-blind studies was the change from baseline in absolute OFF-time based on patient diaries. RESULTS: Double-blind treatment with opicapone (25 and 50mg) significantly reduced absolute daily OFF-time from a baseline of 6.1-6.6 hours. The mean [95%CI] treatment effect vs. placebo was -35.1 [-62.1, -8.2] minutes (p=0.0106) for the 25mg dose and -58.1 [-84.5, -31.7] minutes (p<0.0001) for the 50mg dose. Reductions in OFF-time were mirrored by significant increases in ON-time without troublesome dyskinesia (p<0.05 and p<0.0001, for the 25mg and 50mg doses, respectively). No significant differences were observed for ON-time with troublesome dyskinesia. Patient diary results from the open-label phase indicated a maintenance of effect for patients previously treated with opicapone 50 mg. The group previously treated with the 25mg dose benefited with further optimization of therapy during the open-label phase, while switching from placebo to opicapone led to significant reductions in OFF-time and increased ON-time. CONCLUSIONS: Over at least one year of open-label therapy, opicapone consistently reduced OFF-time and increased ON-time without increasing the frequency of troublesome dyskinesia.
%Z Copyright © 2019 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.