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

CompletedPhase 3

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Conditions: Parkinson's Disease

Interventions: HRG2010; Sustained-release Carbidopa/Levodopa administered placebo, Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Countries: China

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 overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Beijing, Beijing Municipality, China