NCT01060878已完成2 期
Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks
Phytopharm110 个研究点 分布在 3 个国家目标入组 425 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 110
- 主要终点
- Unified Parkinson's Disease Rating Scale parts II & III combined score
研究概览
简要总结
A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
- •subjects who are not currently receiving any PD treatment
排除标准
- •female of child-bearing potential
- •history of neurosurgical procedures for PD
- •history of severe psychiatric illness
研究组 & 干预措施
Dose II
Experimental
干预措施: PYM50028 (Drug)
Dose I
Experimental
干预措施: PYM50028 (Drug)
Dose III
Experimental
干预措施: PYM50028 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale parts II & III combined score
时间窗: 28 Weeks
次要结局
未报告次要终点
研究者
研究点 (110)
Loading locations...
相似试验
Unknown
2 期
Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT03790982Zhejiang Hisun Pharmaceutical Co. Ltd.240
已完成
2 期
Safety and Effect on Memory of PYM50028 in Mild Alzheimer's DiseaseAlzheimer's DiseaseNCT00130429Phytopharm250
已完成
2 期
A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor MutationsCarcinoma, Non-Small-Cell LungNCT01897480Eli Lilly and Company168
招募中
2 期
Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in ChinaCOVID-19NCT05682599Shanghai Henlius Biotech300
终止
2 期
CY-503 for the Treatment of Chemotherapy-refractory Metastatic Colorectal CancerMetastatic Colorectal CancerNCT00932724Cytavis Biopharma GmbH77