Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 14 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06596876
Start Date
November 6 2024
End Date
February 14 2027
Last Update
May 2 2025
Active Locations (1)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730