Category: Parkinson’s Disease: Clinical Trials
Objective: To evaluate the effect on slowing motor progression and the safety of prasinezumab, a humanized monoclonal antibody targeting aggregated alpha-synuclein, in individuals with early Parkinson’s disease (PD) on stable symptomatic therapy.
Background: Results from the double-blind part of the PASADENA Phase II study, multicenter, randomized, placebo-controlled trial evaluating the safety and efficacy of intravenous prasinezumab, administered every 4 weeks, in early-stage PD showed that prasinezumab reduced 1-year motor progression as measured by MDS-UPDRS part III compared to placebo in individuals with early-stage PD.
Method: PADOVA is a Phase IIb, randomized, double blind, placebo-controlled multicenter study. Individuals with early PD will receive monthly intravenous doses of prasinezumab 1,500 mg or placebo for at least 76 weeks, followed by a 2-year extension with all participants on active treatment. Key inclusion criteria are: age 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 inhibitor (MAO-Bi) or levodopa.
Results: The PADOVA study enrolled 586 individuals with early-stage PD. Of these, 74.4% were on stable doses of levodopa (n=436) and 25.6 % on MAO-Bi (n=150). The PADOVA study population was slightly more advanced than PASADENA in terms of disease duration (18.6 vs 10.1 mo), H&Y stage (stage II 83.9% vs 75.3%) and MDS-UPDRS part III (24.5 vs 21.5 points).
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.
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, G. Respondek, A. Monnet, N. Shariati, L. Rutten-Jacobs, 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. 2024; 39 (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-2/. Accessed October 4, 2024.« Back to 2024 International Congress
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-2/