Category: Parkinson’s Disease: Clinical Trials
Objective: The study will evaluate the efficacy and safety of prasinezumab in individuals with early-stage Parkinson’s disease (PD) on stable symptomatic therapy.
Background: Available treatments for PD do not slow clinical progression. Alpha synuclein is a key driver of PD pathology. Prasinezumab is a humanized monoclonal antibody that binds to aggregated alpha-synuclein. Results from a previous phase 2 study showed that prasinezumab reduced 1-year motor progression measured by MDS-UPDRS part III compared to placebo in individuals with early-stage PD (PASADENA).
Method: The PADOVA study is a randomized, double-blind, placebo-controlled multicenter study. Individuals with early PD, recruited across North America and Europe, will receive monthly intravenous doses of prasinezumab 1,500 mg or placebo for at least 76 weeks, followed by a 2-year extension in which all participants receive active treatment. Key inclusion criteria are: aged 50-85 years; Diagnosis of idiopathic PD based on MDS criteria; Hoehn & Yahr (H&Y) Stage I or II; time from diagnosis 3 months to 3 years; DAT-SPECT imaging consistent with PD; and on a stable dose of monoamine oxidase B (MAO-B) inhibitor or levodopa. Study design assumptions for sample size and study duration were built using a patient cohort from the Parkinson’s Progression Marker Initiative (PPMI) and PASADENA. We report baseline characteristics for the MAO-B inhibitor- and levodopa-treated PADOVA cohorts and compare the PADOVA, PASADENA and PPMI populations.
Results: Baseline demographic characteristics, motor and non-motor symptoms (assessed using MDS-UPDRS) will be presented.
Conclusion: The PADOVA study population is suitable for investigating the potential of prasinezumab to slow disease progression in individuals with early PD on stable symptomatic therapy. Trial Registration: NCT04777331.
To cite this abstract in AMA style:T. Nikolcheva, G. Pagano, N. Pross, T. Simuni, K. Marek, R. Postuma, N. Pavese, F. Stocchi, K. Seppi, A. Monnet, N. Shariati, L. Rutten-Jacobs, S. Zanigni, T. Kustermann, K. Taylor, D. Trundell, H. Svoboda, A. Bonni, P. Fontoura, R. Doody. A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson’s Disease (PADOVA): Rationale, Design, and Baseline Data [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/a-study-to-evaluate-the-efficacy-and-safety-of-intravenous-prasinezumab-in-participants-with-early-parkinsons-disease-padova-rationale-design-and-baseline-data/. Accessed September 23, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-study-to-evaluate-the-efficacy-and-safety-of-intravenous-prasinezumab-in-participants-with-early-parkinsons-disease-padova-rationale-design-and-baseline-data/