Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Sep 23, 2024

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female participants diagnosed at age ≥ 40 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) ≥ 25 at Screening Visit.
• • 3. Hoehn and Yahr Stage II-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. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
• • 5. In the opinion of the clinical investigator, Subjects who should not participate in the study.