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

This study has been completed.
Sponsor:
Collaborator:
Vigconic (International) Ltd.
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00517842
First received: August 15, 2007
Last updated: September 3, 2013
Last verified: July 2013
  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
Study Completion Date: September 2008
  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:

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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.
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: September 3, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 23, 2014