NCT06596876已完成3 期
A Randomized, Controlled, Double-blind, Double-dummy, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Change from baseline in "Off" time at Week 21
研究概览
简要总结
The study is a multicenter, randomized, double-blind, double-dummy, active-controlled, Phase III clinical study. The aim of this trial is to evaluated the efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease With Motor Fluctuations.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female who are at age 40~80 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) ≥ 24 at Screening Visit.
- •Hoehn and Yahr Stage I-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.
- •Nonresponsive to LD therapy.
- •In the opinion of the clinical investigator, Subjects who should not participate in the study.
- •Subjects who are allergic to the investigational drug to be used in this study.
- •Pregnant or breastfeeding.
- •Participants who have previously participated in an HRG2010 study.
研究组 & 干预措施
HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo
Experimental
干预措施: HRG2010; Sustained-release Carbidopa/Levodopa administered placebo (Drug)
Sustained-release Carbidopa/Levodopa and HRG2010 placebo
Active Comparator
干预措施: Sustained-release Carbidopa/Levodopa; HRG2010 placebo (Drug)
结局指标
主要结局
Change from baseline in "Off" time at Week 21
时间窗: Last three days collected at the end of treatment period, at Week 21
次要结局
- Change from baseline in "On" Time Without Troublesome Dyskinesia at Week 21(Last three days collected at the end of treatment period, at Week 21)
- Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Week 21(Week 21)
- Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21(Week 21)
- Adverse events(Week 23)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Celebrex In Acute Gouty Arthritis StudyArthritis, GoutyNCT00549549Pfizer's Upjohn has merged with Mylan to form Viatris Inc.402
已完成
3 期
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to StatinsHyperlipidemiaNCT02135029Pfizer184
招募中
3 期
A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy InfantsYellow FeverNCT05447377Serum Institute of India Pvt. Ltd.2,216
已完成
3 期
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic ChemotherapyChemotherapy-induced Nausea and VomitingNCT01500213Tesaro, Inc.555
已完成
3 期
A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARILYellow FeverNCT05421611Serum Institute of India Pvt. Ltd.1,824