A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517842
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : September 5, 2013
Vigconic (International) Ltd.
Information provided by:
Hospital Authority, Hong Kong

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: ViNeuro Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2005
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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. ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • A subject will be eligible for study participation if he/she meets all the following criteria:

    1. Age of at least 30 years
    2. Diagnosis of symptomatic, idiopathic Parkinson' disease using The United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria (Appendix 3 in the protocol)
    3. Stage 1-4 on the modified Hoehn and Yahr scale (Appendix 4 in the protocol)
    4. 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
    5. 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
    6. 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:

    1. Presence of atypical parkinsonian syndromes
    2. Dementia as defined by the Mini-Mental State Examination score (Appendix 5 in the protocol) of 22 or less
    3. Serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease
    4. Used centrally active therapies, e.g. hypnotics, antidepressants, anxiolytics, within 60 days before study entry
    5. Used methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-A inhibitors, e.g. pargyline, phenelzine, or tranylcpromine, within 3 months of study entry
    6. Has history of receiving any neuroleptics
    7. Used alpha-methyldopa or flunarizine within 6 months of study entry
    8. Females who are pregnant or breastfeeding.
    9. 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).
    10. 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).
    11. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517842

Prince of Wales Hospital
Hong Kong, China
Princess Margaret Hospital
Hong Kong, China
Queen Elizabeth Hospital
Hong Kong, China
Tseung Kwan O Hospital
Hong Kong, China
United Christian Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Vigconic (International) Ltd.
Principal Investigator: Jonas HM Yeung, Dr Department of Medicine and Therapeutics, Prince of Wales Hospital/ The Chinese University of Hong Kong

Additional Information: Identifier: NCT00517842     History of Changes
Other Study ID Numbers: CRE-2005-228-T
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: July 2013

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