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Lookup NU author(s): Professor Nicola PaveseORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2025 The AuthorsIntroduction: Prasinezumab was shown to potentially delay motor progression in individuals with early-stage Parkinson's disease (PD) who were either treatment-naïve or on monoamine oxidase type B inhibitor (MAO-Bi) therapy in the PASADENA study. We report the rationale, design, and baseline patient characteristics of the PADOVA study, designed to evaluate prasinezumab in an early-stage PD population receiving standard-of-care (SOC) symptomatic medications. Methods: PADOVA (NCT04777331) is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, in which individuals with early-stage PD on SOC stable symptomatic monotherapy (levodopa or MAO-Bi) receive intravenous prasinezumab 1500 mg every 4 weeks. The primary endpoint is time to confirmed motor progression, defined as ≥5 points increase from baseline on the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III in practically defined OFF-medication state. Results: 586 participants were enrolled between May 5th, 2021 and March 22nd, 2023. At baseline, 74.2 % and 25.8 % of participants were receiving levodopa and MAO-Bi, respectively. Mean age was 64.2 years and 63.5 % were male. Mean time from diagnosis was 18.6 months, 85 % of participants were in Hoehn & Yahr (H&Y) Stage 2, and mean MDS-UPDRS Part III score was 24.5. Compared with the PASADENA population, PADOVA participants were older (∼5 years), with longer disease duration (∼8 months), and slightly more advanced based on H&Y stage (10 % more in Stage 2) and MDS-UPDRS Part III (∼3 points more). Conclusions: PADOVA has successfully recruited an early-stage PD population to test the effect of prasinezumab when added to background SOC.
Author(s): Nikolcheva T, Pagano G, Pross N, Simuni T, Marek K, Postuma RB, Pavese N, Stocchi F, Seppi K, Monnet A, Shariati N, Ricci B, Rutten-Jacobs L, Respondek G, Kustermann T, Taylor KI, Trundell D, Fontoura P, Doody R, Svoboda H, Bonni A
Publication type: Article
Publication status: Published
Journal: Parkinsonism and Related Disorders
Year: 2025
Volume: 132
Print publication date: 01/03/2025
Online publication date: 29/12/2024
Acceptance date: 28/12/2024
Date deposited: 21/01/2025
ISSN (print): 1353-8020
ISSN (electronic): 1873-5126
Publisher: Elsevier Ltd
URL: https://doi.org/10.1016/j.parkreldis.2024.107257
DOI: 10.1016/j.parkreldis.2024.107257
Data Access Statement: Data sharing is not applicable to this article as no datasets were generated or analyzed during this study.
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