Parkinson's DiseasePhase 3NCT01016470
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
A Phase 3 study testing VIUSID/ALZER in people with Parkinson's Disease, run by Catalysis SL at 1 site in Cuba.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- VIUSID/ALZER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCuba
- Study dates
- Oct 2009to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical of PD, with the criteria of Brain Bank of London with early stage.
- Informed consent.
Who cannot join
- Presence of another disease not well controlled.
- Patient with atypical features.
- Patient with advanced Parkinson's disease.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson's Disease
- Being tested
- VIUSID/ALZER, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIUSID/ALZERDietary supplement
VIUSID/ALZER, 3 per day, oral, one year
PlaceboDietary supplement
Placebo Viusid and Placebo Alzer, 3 per day, oral, one year
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| A | Experimental | 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 Receives: Dietary Supplement: VIUSID/ALZER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year
Secondary outcomes (2)
Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)
Measured: one year
Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Luis Guiroud, PhD, Principal investigator, "Salvador Allende" Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016470
- Sponsor's protocol ID
- CAT-0916-CU
- Status last verified
- May 2012
- First submitted
- 28 Sep 2009
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01016470
- Acronym / sponsor ID
- CAT-0916-CU
- Conditions
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| A | Experimental | Dietary Supplement: VIUSID/ALZERVIUSID/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 |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with clinical of PD, with the criteria of Brain Bank of London with early stage.
- Informed consent.
Key exclusion criteria (3 listed)
- Presence of another disease not well controlled.
- Patient with atypical features.
- Patient with advanced Parkinson's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIUSID/ALZERVIUSID/ALZER, 3 per day, oral, one year | Dietary supplement | A |
| PlaceboPlacebo Viusid and Placebo Alzer, 3 per day, oral, one year | Dietary supplement | B |
Primary outcome
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
2 secondary outcomes
Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)
Time frame: one year
Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Guiroud, PhD principal investigator
"Salvador Allende" Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VIUSID/ALZER in people with Parkinson's Disease, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2012.