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.

Ferreira, JJ, Lees, A ORCID: 0000-0002-2476-4385, Rocha, J-F, Poewe, W, Rascol, O and Soares-da-Silva, P (2019) 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. Eur J Neurol, 26 (7). pp. 953-960.

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Official URL: https://www.ncbi.nlm.nih.gov/pubmed/30681754

Abstract

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. This article is protected by copyright. All rights reserved.

Item Type:	Article
Additional Information:	publicationstatus: online-published
Uncontrolled Keywords:	OFF time, Opicapone, Parkinson’s disease, motor fluctuations
Depositing User:	Symplectic Admin
Date Deposited:	22 May 2019 13:46
Last Modified:	19 Jan 2023 00:43
DOI:	10.1111/ene.13914
Open Access URL:	https://doi.org/10.1111/ene.13914
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3042479