A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

Timeline

Start

2021-05-05

Primary completion

2024-09-11

Completion

2031-06-30

Outcome

Missed primary endpoint

paper The primary endpoint was not met; the primary analysis showed a non-significant delay in motor progression with prasinezumab versus placebo PMID 42208564 ↗

registry analysis (superiority test); DBT Period: Placebo vs DBT Period: Prasinezumab; p = 0.0657; Hazard Ratio (HR) 0.84 (95% CI 0.69 to 1.01); Log Rank NCT04777331 ↗

release “Prasinezumab Parkinson’s disease Phase IIb study of prasinezumab misses primary endpoint, but suggests possible benefit in early-stage Parkinson’s disease PADOVA study showed numerical delay” roche.com ↗

release “Phase 2b PADOVA clinical trial ( NCT04777331 ) in patients with early-stage Parkinson’s disease missed the primary endpoint” prothena.com ↗

release “Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01], although the study missed statistical significance” prothena.com ↗

Publications

• Nikolcheva T, Pagano G, Anzures-Cabrera J, Trundell D, Kustermann T, Simuni T, Marek K, Pavese N, Seppi K, Stocchi F, Postuma RB, Pross N, Monnet A, Respondek G, Schlegel V, Boak L, Rutten-Jacobs L, Kerchner GA, Brundin P, Svoboda H, Bonni A; PADOVA Investigators; Prasinezumab Study Group. Efficacy and safety of intravenous prasinezumab in individuals with early-stage Parkinson's disease on stable symptomatic monotherapy (PADOVA): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study. Lancet. 2026 May 30;407(10544):2227-2240. doi: 10.1016/S0140-6736(26)00865-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prasinezumab	Monoclonal antibody	1500 mg	Intravenous

Indications