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

Hengrui Medicine

Status and phase

Enrolling

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Drug: HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06596876

HRG2010-301

Details and patient eligibility

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.

Enrollment

450 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
Mini Mental State Examination (MMSE) ≥ 24 at Screening Visit.
Hoehn and Yahr Stage I-IV when "on" at Screening Visit.
At Screening, the participant has predictable "Off" periods.
Able and willing to provide a written informed consent.

Exclusion criteria

Diagnosed with atypical or secondary parkinsonism.
History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
Nonresponsive to LD therapy.
In the opinion of the clinical investigator, Subjects who should not participate in the study.
Subjects who are allergic to the investigational drug to be used in this study.
Pregnant or breastfeeding.
Participants who have previously participated in an HRG2010 study.