Parkinson's Disease
Conditions
Brief 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.
Interventions
DRUGHRG2010; Sustained-release Carbidopa/Levodopa administered placebo
Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.
DRUGSustained-release Carbidopa/Levodopa; HRG2010 placebo
Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in "Off" time at Week 21 | Last three days collected at the end of treatment period, at Week 21 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in "On" Time Without Troublesome Dyskinesia at Week 21 | Last three days collected at the end of treatment period, at Week 21 |
| Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Week 21 | Week 21 |
| Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21 | Week 21 |
| Adverse events | Week 23 |
Countries
China
Outcome results
None listed