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A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
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 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease With Motor Fluctuations.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2024-11-06
Completion Date
2027-02-14
Last Updated
2025-05-02
Healthy Volunteers
No
Conditions
Interventions
HRG2010; Sustained-release Carbidopa/Levodopa administered placebo
Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.
Sustained-release Carbidopa/Levodopa; HRG2010 placebo
Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.
Locations (1)
Beijing Hospital
Beijing, Beijing Municipality, China