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

September 3, 2013 updated by: Hospital Authority, Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Queen Elizabeth Hospital
      • Hong Kong, China
        • Prince of Wales Hospital
      • Hong Kong, China
        • Princess Margaret Hospital
      • Hong Kong, China
        • United Christian Hospital
      • Hong Kong, China
        • Tseung Kwan O Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 24 Weeks
24 Weeks

Secondary Outcome Measures

Outcome Measure
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...
Time Frame: 24 weeks
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.
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 16, 2007

First Posted (Estimate)

August 17, 2007

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2005-228-T
  • HARECCTR0500017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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