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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01016470 |
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Date of registration:
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28/09/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease
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Scientific title:
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Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01016470 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Jose Luis Guiroud, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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"Salvador Allende" Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with clinical of PD, with the criteria of Brain Bank of London with early
stage.
- Informed consent.
Exclusion Criteria:
- Presence of another disease not well controlled.
- Patient with atypical features.
- Patient with advanced Parkinson`s disease.
Age minimum:
20 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson`s Disease
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: VIUSID/ALZER
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Primary Outcome(s)
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Periodical measures of the clinical features with Unified Parkinson Disease Rating Scale (UPDRS) will be done at the beginning, every three months until one year (end of the treatment)
[Time Frame: one year]
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Secondary Outcome(s)
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Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)
[Time Frame: one year]
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Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)
[Time Frame: one year]
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Secondary ID(s)
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CAT-0916-CU
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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