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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This study is to evaluate the effictiveness and safety of Ly03003 following intramuscular injections
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03003(Rotigotine,extended-release microspheres) | Drug | During the intervention, the initial dose was 14mg, and then was incremented in weekly units, 14mg each time, until the maximum dose of 56mg set in this study was reached 4 weeks after titration, the optimal therapeutic dose or the maximum tolerated dose was entered into the dosing maintenance period. After entering the maintenance period, no dose adjustment was performed, and the stable dose was maintained for 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale(UPDRS)part(Ⅱ+Ⅲ)Total Score | From baseline to the end of the double-blind dose maintenance period at 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients whose total UPDRS decreased by 20、25、30percent or mors | From baseline to the end of the double-blind dose maintenance period at 24weeks | |
| UPDRS scale part Ⅱchanges relative to the baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo,extended-release microspheres | Drug | During the intervention,the initial does was 14mg,and then was incremented in weekly units,14mg each time,until the maximum does of 56mg set in this study was reached 4 weeks after titration,the optimal therapeutic does or the maximum tolerated does was entered into the dosing maintenance period.After entering the maintenance period,no does adjustment was performed,and the stable does was maintained for 24 weeks. |
|
| UPDRS scale part Ⅲchanges relative to the baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks |
| Changes in SI scores in the Total Clinical Efficacy Rating Scale (CGI) relative to baseline,the scores of GI and EI | From baseline to the end of the double-blind dose maintenance period at 24weeks |
| To clarify the changes in PDQ-8 questionnaire scores relative to baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks |
| To clarify the changes in PDSS questionnaire scores relative to baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks |
| To clarify the changes in BDI-Ⅱquestionnaire scores relative to baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |