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Completed NCT06596876

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

Conditions: Parkinson's Disease

Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 165
Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Location: Beijing Hospital Beijing Beijing Municipality

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 Criteria

Inclusion Criteria: 1. 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. 2. Mini Mental State Examination (MMSE) ≥ 24 at Screening Visit. 3. Hoehn and Yahr Stage I-IV when "on" at Screening Visit. 4. At Screening, the participant has predictable "Off" periods. 5. Able and willing to provide a written informed consent. Exclusion Criteria: 1. Diagnosed with atypical or secondary parkinsonism. 2. History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage. 3. Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period. 4. Nonresponsive to LD therapy. 5. In the opinion of the clinical investigator, Subjects who should not participate in the study. 6. Subjects who are allergic to the investigational drug to be used in this study. 7. Pregnant or breastfeeding. 8. Participants who have previously participated in an HRG2010 study.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06596876). StuddyBuddy aggregates publicly available trial information.