NCT06614153已完成2 期
A Randomized, Open-label, Controlled, Single-dose, Multiple-dose Phase II Study to Evaluate the Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change from baseline in average percent "Off" time during waking hours at Day 33
研究概览
简要总结
The study is a multicenter, randomized, open-label, active-controlled, Phase II clinical study. The aim of this trial is to evaluated the pharmacokinetics, pharmacodynamics,efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease Patients With Motor Fluctuations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants diagnosed at age ≥ 40 years with PD, consistent with the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria and who are being treated with stable regimens of DDCI+LD but experiencing motor fluctuations.
- •Mini Mental State Examination (MMSE) ≥ 25 at Screening Visit.
- •Hoehn and Yahr Stage II-IV when "on" at Screening Visit.
- •At Screening, the participant has predictable "Off" periods.
- •Able and willing to provide a written informed consent.
排除标准
- •Diagnosed with atypical or secondary parkinsonism.
- •History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
- •Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
- •In the opinion of the clinical investigator, Subjects who should not participate in the study.
研究组 & 干预措施
Group A，Subjects will receive HRG2010(I)
Experimental
administered orally
干预措施: HRG2010(I) (Drug)
Group B，Subjects will receive HRG2010(II)
Experimental
administered orally
干预措施: HRG2010(II) (Drug)
Group C，Subjects will receive Sustained-release
Active Comparator
Carbidopa/Levodopa administered orally
干预措施: Sustained-release Carbidopa/Levodopa (Drug)
结局指标
主要结局
Change from baseline in average percent "Off" time during waking hours at Day 33
时间窗: Last three days collected at the end of treatment period
次要结局
- MDS-UPDRS Part III(Days 1 and 33)
- Change from baseline in "Off" time at Day 33(Last three days collected at the end of treatment period)
- "Off" and"On" time hours during in clinic observation(Days 1 and 13)
- Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Day 33(Day 33)
研究者
研究点 (1)
Loading locations...
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