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Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01016470
First received: September 28, 2009
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with Parkinson's Disease (PD).


Condition Intervention Phase
Parkinson`s Disease
 Dietary Supplement: VIUSID/ALZER
Dietary Supplement: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B
Placebo
 Dietary Supplement: Placebo
Placebo Viusid and Placebo Alzer, 3 per day, oral, one year
Experimental: A
VIUSID/ALZER. The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with early PD by UPDRS motor
 Dietary Supplement: VIUSID/ALZER
VIUSID/ALZER, 3 per day, oral, one year

Detailed Description:

Periodical measures of the clinical features with UPDRS will be done at the beginning, each three months until two years. Each group will be compare to evaluate.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016470

Locations
Cuba
"Salvador Allende Hospital"
Havana City, Havana, Cuba
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Jose Luis Guiroud, PhD "Salvador Allende" Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT01016470     History of Changes
Other Study ID Numbers: CAT-0916-CU
Study First Received: September 28, 2009
Last Updated: May 2, 2012
Health Authority: Cuba: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013