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| Name | Class |
|---|---|
| Beijing Bozhiyin T&S Co., Ltd. | INDUSTRY |
This study is to characterize the pharmacokinetics and to evaluate the safety as well as tolerability of LY03003 following multiple escalating intramuscular injections
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine, extended-release microspheres | Drug | Four stable dose levels of LY03003 at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:
|
| Measure | Description | Time Frame |
|---|---|---|
| LY03003 concentration in plasma | Days 1, 2, 4, 6, 8, 15, 22, 29, 30, 32, 34, 36, 38, 40, 43, and day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Adverse events to evaluate the safety and tolerability of LY03003 | From screening up to day 50 |
| Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅲ) Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| C047508 | rotigotine |
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|
| Placebo, extended-release microspheres | Drug | Four stable dose levels of placebo at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:
|
|
The Unified Parkinson´s Disease Rating Scale Part Ⅲ is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 (Best score possible) to 108 (Worst score possible). |
| screening, baseline and day 29 and Day 50 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |