Objective: To describe the results of PASADENA 1-year open-label extension (OLE).

Background: Prasinezumab is a humanized monoclonal antibody that binds aggregated alpha-synuclein with the potential to slow disease progression in Parkinson’s disease (PD). PASADENA (NCT03100149) is a multicentre, randomized, double-blind, placebo-controlled study evaluating the efficacy of prasinezumab in participants with early-stage PD.

Method: Participants with early-stage PD (diagnosis ≤2 years of age at screening; Hoehn & Yahr Stages I–II) were randomized to receive intravenous prasinezumab every 4 weeks (1500 mg or 4500mg) for two years (early-start group), or placebo for 52 weeks followed by prasinezumab (1500 mg or 4500 mg) for one year (delayed-start group). A total of 271 participants (out of the original 316) rolled over into a 5-year open-label extension, after a treatment-free period of 6 months on average. We describe here the continuous change from baseline at the end of 1-year open-label extension on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III, Part II, and  Part III+II, which was analyzed longitudinally using Mixed Model for Repeated Measures (MMRM) methodology. Participants were considered in the analysis regardless of the dose, type, or change of their symptomatic therapy. Real-world data were used as a comparator to put the results into context.

Results: Baseline characteristics were balanced between groups. Results from Part 3 will be described and put into context.

Conclusion: The PASADENA Part 3 OLE is currently ongoing, and we aim to describe the long-term safety and efficacy on a yearly basis.

« Back to 2023 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/pasadena-1-year-open-label-extension/