RecruitingPhase 3NCT06596876

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

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


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

450 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug called HRG2010 can help reduce the unpredictable "off" periods that Parkinson's disease patients experience — times when their levodopa medication stops working and symptoms suddenly worsen. **You may be eligible if...** - You are between 40 and 80 years old - You have been diagnosed with Parkinson's disease - You are taking levodopa with a stable dose but still experience motor fluctuations ("off" periods) - You score 24 or above on the Mini Mental State Exam - You have predictable "off" periods **You may NOT be eligible if...** - You have atypical or secondary parkinsonism (not classic Parkinson's) - You have narrow angle glaucoma, peptic ulcer disease, or GI bleeding history - You have had prior brain surgery for Parkinson's - Levodopa does not work for you - You are pregnant or breastfeeding - You have previously participated in an HRG2010 study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRG2010; Sustained-release Carbidopa/Levodopa administered placebo

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

DRUGSustained-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

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NCT06596876


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