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| ID | Type | Description | Link |
|---|---|---|---|
| HARECCTR0500017 |
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| Name | Class |
|---|---|
| Vigconic (International) Ltd. | INDUSTRY |
The investigational product is a specially formulated TCM and administered in the form of a capsule.
Basic pre-clinical studies have suggested that it may have good immunomodulating functions, increases the activities of T-cells, B-cells and NK cells, enhances mitochondrial antioxidant status on various tissues including brain tissues. Therefore, this formulation may have special values in improving symptoms in Parkinson's disease patients.
The purpose of the study is to determine the efficacy and safety of ViNeuro in patients with Parkinson's disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViNeuro | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy outcome is the change from baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) (Appendix 6) Parts II and III total scores at the end of 24 weeks. The UPDRS is to be performed one hour after L-dopa treatment. | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the individual Part II and Part III total scores, sum of Parts I-III total scores, Part IV total score of the UPDRS at each follow-up visit... | 24 weeks | |
| Change from baseline in the number of "off" hours throughout the study at each follow-up visit. |
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Inclusion Criteria:
A subject will be eligible for study participation if he/she meets all the following criteria:
Exclusion Criteria:
A subject will be excluded from the study if he/she meets any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonas HM Yeung, Dr | Department of Medicine and Therapeutics, Prince of Wales Hospital/ The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | China | ||||
| Princess Margaret Hospital |
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| The mean number of daily "off" hours over the last 7 days before each study visit, except for the screening visit, will be used for the analysis. |
| Change from baseline in the total daily dose in patients who received concomitant levodopa therapy throughout the study at each follow-up visit; Change from baseline in Red Cell Superoxide Dismutase Activity at 24 week. | 24 weeks |
| Hong Kong |
| China |
| Queen Elizabeth Hospital | Hong Kong | China |
| Tseung Kwan O Hospital | Hong Kong | China |
| United Christian Hospital | Hong Kong | China |
| 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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