A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ViNeuro
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease
Eligibility 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.
Sites / Locations
- Prince of Wales Hospital
- Princess Margaret Hospital
- Queen Elizabeth Hospital
- Tseung Kwan O Hospital
- United Christian Hospital
Outcomes
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.
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...
Change from baseline in the number of "off" hours throughout the study at each follow-up visit.
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.
Full Information
NCT ID
NCT00517842
First Posted
August 15, 2007
Last Updated
September 3, 2013
Sponsor
Hospital Authority, Hong Kong
Collaborators
Vigconic (International) Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00517842
Brief Title
A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease
Official Title
A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Vigconic (International) Ltd.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ViNeuro
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas HM Yeung, Dr
Organizational Affiliation
Department of Medicine and Therapeutics, Prince of Wales Hospital/ The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
China
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
China
Facility Name
Tseung Kwan O Hospital
City
Hong Kong
Country
China
Facility Name
United Christian Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease
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