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
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.
• 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.