Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 255
- 试验地点
- 61
- 主要终点
- Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks
研究概览
简要总结
This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria or Movement Disorder Society Research Criteria
- •Patients with Parkinson's disease according to protocol specified scale assessments
- •DaTscan consistent with diagnosis of Parkinson's Disease
- •Men or women 30 to 80 years of age
排除标准
- •Diagnosis of secondary or atypical parkinsonism
- •Prior use of dopaminergic treatment or MAO-B inhibitors for more than 28 days
- •Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit
- •Pregnant or planning to become pregnant
- •Metabolic, surgical, psychiatric or laboratory abnormality that would interfere with study compliance or safety in the judgment of the investigator
研究组 & 干预措施
NLY01 (2.5 mg)
NLY01 2.5 mg injection
干预措施: NLY01 (Drug)
NLY01 (5.0 mg)
NLY01 5.0 mg injection
干预措施: NLY01 (Drug)
Vehicle
inactive drug, injection
干预措施: Vehicle (Drug)
结局指标
主要结局
Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks
时间窗: 36 weeks
This is the Unified Parkinson's Disease Rating Scale assessment (MDS-UPDRS). The investigator will assess II and III components of the Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale Part II assesses motor aspects of experiences of daily living. The Unified Parkinson's Disease Rating Scale Part III assesses motor signs of Parkinson's Disease. The Unified Parkinson's Disease Rating Scale is a widely used assessment to quantify the signs and symptoms of Parkinson's Disease. Each subscale has 0-4 ratings, where 0=normal, 1=slight, 2=mild, 3=moderate and 4=severe. The scale is completed by the investigator and scores are derived from clinician and subject input to allow the assessment of symptomatic worsening and improvement.
次要结局
未报告次要终点