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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo | Experimental |
| |
| Sustained-release Carbidopa/Levodopa and HRG2010 placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRG2010; Sustained-release Carbidopa/Levodopa administered placebo | Drug | Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in "Off" time at Week 21 | Last three days collected at the end of treatment period, at Week 21 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
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| Sustained-release Carbidopa/Levodopa; HRG2010 placebo | Drug | Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally. |
|
| Week 21 |
| Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21 | Week 21 |
| Adverse events | Week 23 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
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