BENITIONSClinical Trial Intelligence

A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease

2期 进行中(已停止招募) NCT03100149

适应症Parkinson's Disease
分期2期
申办方Hoffmann-La Roche
状态进行中(已停止招募)
受试者人数316 人
干预(药物)RO7046015, RO7046015
开始日期2017年6月27日
完成日期2019年11月27日
结果公布日2021年2月8日

摘要

This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 520 weeks.

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52

From baseline to Week 52 · Units on a scale

Part 1: Placebo9.37 ± 1.221 Units on a scale
Part 1: RO7046015 Low Dose7.35 ± 1.225 Units on a scale
Part 1: RO7046015 High Dose8.75 ± 1.234 Units on a scale
p-value0.2385
Difference in Adjusted Means-2.02 (95% CI -4.21–0.18)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。