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RECRUITING
NCT06596876
PHASE3

A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.

DRUG

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