RECRUITINGPhase 3INTERVENTIONAL
A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
HRG2010; Sustained-release Carbidopa/Levodopa administered placebo
Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.
DRUG
Sustained-release Carbidopa/Levodopa; HRG2010 placebo
Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.
Locations (1)
Beijing Hospital
Beijing, Beijing Municipality, China