MDS 2022 | Exploratory delayed-start analysis of PASADENA in early-stage Parkinson’s disease
The PASADENA trial (NCT03100149) evaluated the safety and efficacy of prasinezumab in early Parkinson’s disease. The first part of the study did not meet the primary endpoint, change in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Total score (Parts I + II + III); however, differences in MDS-UPDRS Part III scores suggest less motor progression in prasinezumab-treated participants than in the placebo group. Gennaro Pagano, MD, MSc, PhD, F. Hoffmann – La Roche Ltd, Basel, Switzerland, discusses the results of an exploratory delayed-start analysis of PASADENA evaluating the efficacy of prasinezumab on motor progression and motor complications in early-stage Parkinson’s disease. Participants were randomized to receive intravenous prasinezumab every four weeks for 104 weeks (early-start group, or placebo for 52 weeks, followed by prasinezumab for 52 weeks (delayed-start group, n=105). Results showed that fewer patients in the early-start group showed motor progression compared with the delayed-start group. Additionally, fewer participants in the early-start group developed motor complications compared with the delayed-start group. This interview took place at the 2022 International Congress of Parkinson’s Disease and Movement Disorders in Madrid, Spain.
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Transcript (edited for clarity)
PASADENA is a Phase II, multicenter, randomized control trial in which we compare prasinezumab with placebo in a population of early-stage Parkinson’s disease. The study is organized in three parts. In part one we compare placebo with prasinezumab low-dose versus prasinezumab high-dose. And in the second part of the study, all patients that were treated with prasinezumab, low or high dose, were continued on until the end of the second year, and all patients randomized on placebo were re-randomized to prasinezumab low and high dose...
PASADENA is a Phase II, multicenter, randomized control trial in which we compare prasinezumab with placebo in a population of early-stage Parkinson’s disease. The study is organized in three parts. In part one we compare placebo with prasinezumab low-dose versus prasinezumab high-dose. And in the second part of the study, all patients that were treated with prasinezumab, low or high dose, were continued on until the end of the second year, and all patients randomized on placebo were re-randomized to prasinezumab low and high dose.
After the first 2 years of the study, everyone gets randomized to low-dose and continues for 5 years. The study was checking if prasinezumab was able to reduce the global progression of Parkinson’s disease, and we did not see an effect on the MDS-UPDRS total score. That is the primary point. However, we found that in the first year of the study, prasinezumab was able to reduce the motor progression of Parkinson’s disease, measured with MDS-UPDRS Part III. When we look at the second year, all patients that early start or patients that start in the first year and do prasinezumab for 2 years, delay start is that patient will start after the first year of placebo. So early start patients were on a better trajectory compared to delay start. So at the end of 2 years, they were having lower score, lower means better, of the MDS-UPDRS part III.
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Disclosures
Dr Pagano is a full-time employee and shareholder at F. Hoffmann – La Roche Ldt.
