A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson’s Disease (NEULARK)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 20
- 主要终点
- Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo Time Frame: From enrollment to the end of treatment at 52 weeks
研究概览
简要总结
To evaluate the safety and primary efficacy of NEU-411 in participants with LRRK2-driven Parkinson’s disease
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase 2 Study of NEU-411 in CDx-Positive Participants with Early Parkinson’s Disease
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 40-80 years at time of screening, inclusive
- •Diagnosis of clinically established or clinically probable Parkinson's disease
- •LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
- •Modified Hoehn and Yahr (mH&Y) of 1 to 2.5
- •Additional inclusion criteria are outlined in the full study protocol.
排除标准
- •Secondary or atypical parkinsonian syndromes
- •Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
- •Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)
- •Additional exclusion criteria are outlined in the full study protocol.
结局指标
主要结局
Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo Time Frame: From enrollment to the end of treatment at 52 weeks
Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo Time Frame: From enrollment to the end of treatment at 52 weeks
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo Time Frame: From enrollment to the end of study at 54 weeks
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo Time Frame: From enrollment to the end of study at 54 weeks
次要结局
- Change from baseline to Week 52 in motor function/nonmotor as measured by Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)
研究者
Fatta Nahab, MD FAAN FANA
Scientific
Neuron23 Inc.