NCT01016470

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

1.6 years

First QC Date

September 28, 2009

Last Update Submit

May 2, 2012

Conditions

Parkinson's Disease

Outcome Measures

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)

    one year

Secondary Outcomes (2)

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

    one year

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

    one year

Study Arms (2)

B

PLACEBO COMPARATOR

Placebo

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

Dietary Supplement: VIUSID/ALZER

Interventions

VIUSID/ALZERDIETARY_SUPPLEMENT

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

A
PlaceboDIETARY_SUPPLEMENT

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

B

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Presence of another disease not well controlled.
  • Patient with atypical features.
  • Patient with advanced Parkinson's disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Salvador Allende Hospital"

Havana, La Habana, Cuba

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Viusid

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jose Luis Guiroud, PhD

    "Salvador Allende" Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2009

First Posted

November 19, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 4, 2012

Record last verified: 2012-05

Locations

CU(1)