ClinicalTrials.gg
CompletedNCT01016470Updated May 4, 2012

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

A Phase 3 interventional study of VIUSID/ALZER and Placebo in Parkinson's Disease, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-05-04.

Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's enrollment of 100 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with clinical of PD, with the criteria of Brain Bank of London with early stage.
  • .

Exclusion criteria

Exclusion Criteria:

  • Presence of another disease not well controlled.
  • Patient with atypical features.
  • Patient with advanced Parkinson's disease.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    B

    Placebo

    Dietary Supplement: Placebo

  • 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

Interventions

  • Dietary supplementVIUSID/ALZER

    Drug page: Viusid

    VIUSID/ALZER, 3 per day, oral, one year

  • Dietary supplementPlacebo

    Placebo Viusid and Placebo Alzer, 3 per day, oral, one year

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)

    Time frame: one year

  2. Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)

    Time frame: one year

07

Study locations

1 site
  • "Salvador Allende Hospital"
    Havana City, Havana, Cuba
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01016470
Lead sponsor
Catalysis SL
Responsible party
Sponsor
First posted
Nov 19, 2009
Start date
Oct 2009
Primary completion
May 2011
Completion
May 2011
Last update
May 4, 2012

Study contacts

Jose Luis Guiroud, PhD
principal investigator · "Salvador Allende" Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Viusid

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