Actively Recruiting
A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-05-02
450
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 40 to 80 years with Parkinson's Disease, meeting International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria and treated with stable DDCI plus levodopa regimens but experiencing motor fluctuations
- Mini Mental State Examination (MMSE) score of 24 or higher at Screening Visit
- Hoehn and Yahr Stage I-IV when "on" at Screening Visit
- Presence of predictable "Off" periods at Screening
- Able and willing to provide written informed consent
You will not qualify if you...
- Diagnosis of atypical or secondary parkinsonism
- History of narrow angle glaucoma, peptic ulcer disease, or upper gastrointestinal hemorrhage
- Prior functional neurosurgical treatment for Parkinson's Disease or planned neurosurgical procedures during study period
- Nonresponsive to levodopa therapy
- Investigator's opinion that subject should not participate
- Allergy to the investigational drug used in the study
- Pregnant or breastfeeding
- Previous participation in an HRG2010 study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
S
Shaomin Wei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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