A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Hospital Authority, Hong Kong
Collaborator:
Vigconic (International) Ltd.
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00517842
First received: August 15, 2007
Last updated: July 6, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson Disease |
Drug: ViNeuro |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease |
Resource links provided by NLM:
Further study details as provided by Hospital Authority, Hong Kong:
Primary Outcome Measures:
- 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. [ Time Frame: 24 Weeks ]
Secondary Outcome Measures:
- 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... [ Time Frame: 24 weeks ]
- Change from baseline in the number of "off" hours throughout the study at each follow-up visit. [ Time Frame: 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. [ Time Frame: 24 weeks ]
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | September 2007 |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
A subject will be eligible for study participation if he/she meets all the following criteria:
- Age of at least 30 years
- Diagnosis of symptomatic, idiopathic Parkinson' disease using The United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria (Appendix 3 in the protocol)
- Stage 1-4 on the modified Hoehn and Yahr scale (Appendix 4 in the protocol)
- Possesses three of the four cardinal signs of Parkinson's disease, i.e. rigidity, bradykinesia, resting tremor and postural instability, without any other known or suspected cause for their parkinsonism
- If receiving levodopa or other symptomatic treatments, the subject should have shown a good response to it and have been on a stable dosage for at least 1 month prior to study entry
- Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures.
Exclusion Criteria:
A subject will be excluded from the study if he/she meets any of the following criteria:
- Presence of atypical parkinsonian syndromes
- Dementia as defined by the Mini-Mental State Examination score (Appendix 5 in the protocol) of 22 or less
- Serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease
- Used centrally active therapies, e.g. hypnotics, antidepressants, anxiolytics, within 60 days before study entry
- Used methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-A inhibitors, e.g. pargyline, phenelzine, or tranylcpromine, within 3 months of study entry
- Has history of receiving any neuroleptics
- Used alpha-methyldopa or flunarizine within 6 months of study entry
- Females who are pregnant or breastfeeding.
- Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study (Visit 1).
- Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to screening of this study (Visit 1).
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517842
Locations
| China | |
| Prince of Wales Hospital | |
| Hong Kong, China | |
| Princess Margaret Hospital | |
| Hong Kong, China | |
| United Christian Hospital | |
| Hong Kong, China | |
| Queen Elizabeth Hospital | |
| Hong Kong, China | |
| Tseung Kwan O Hospital | |
| Hong Kong, China | |
Sponsors and Collaborators
Hospital Authority, Hong Kong
Vigconic (International) Ltd.
Investigators
| Principal Investigator: | Jonas HM Yeung, Dr | Department of Medicine and Therapeutics, Prince of Wales Hospital/ The Chinese University of Hong Kong |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00517842 History of Changes |
| Other Study ID Numbers: | CRE-2005-228-T, HARECCTR0500017 |
| Study First Received: | August 15, 2007 |
| Last Updated: | July 6, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hospital Authority, Hong Kong:
|
Parkinson's disease |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 22, 2013