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 |
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| 分期 | 2期 |
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| 申办方 | Hoffmann-La Roche |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 316 人 |
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| 干预(药物) | RO7046015, RO7046015 |
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| 开始日期 | 2017年6月27日 |
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| 完成日期 | 2019年11月27日 |
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| 结果公布日 | 2021年2月8日 |
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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: Placebo | 9.37 ± 1.221 Units on a scale |
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| Part 1: RO7046015 Low Dose | 7.35 ± 1.225 Units on a scale |
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| Part 1: RO7046015 High Dose | 8.75 ± 1.234 Units on a scale |
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| p-value | 0.2385 |
| Difference in Adjusted Means | -2.02 (95% CI -4.21–0.18) |
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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。