Efficacy of Ethnodyne Visio in Parkinson's Disease (ETHNOPARK)

April 16, 2018 updated by: University Hospital, Strasbourg, France
ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient acting alongside vitamin B2. It is proposed in patients with visual problems. Based on clinical and experimental data, the investigators propose a pilot open study in order to test the efficacy of "Ethnodyne visio" in patients with Parkinson 's disease (PD). The hypothesis is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients with PD will be evaluated before and after 3 months of add on treatment by Ethnodyne visio.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67098
        • Service de Neurologie,Hôpital de Hautepierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Parkinson disease (PD) with at least 3 years of evolution
  • Hoehn and Yahr score 2 or 3
  • with moderate fluctuations (score 1 or 2 for item 3 score IV MSD UPDRS)
  • with no modification in anti-parkinsonian drugs since at least 1 month
  • minimental test >24

Exclusion Criteria:

  • known intolerance to Ethnodyne visio
  • woman of childbearing potential or breastfeeding
  • anticipated anti-parkinsonian treatment modification during the 3 months of the study
  • antidepressant or anxiolytic drugs modified within one month prior to inclusion visit
  • other chronic disease
  • concomitant participation in a another clinical trial
  • Subject under legal guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ETHNODYNE VISIO
Administration 2 times a day of a dietary supplement, as add on therapy, in patients with Parkinson s disease
Dietary supplement: ETHNODYNE VISIO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in MDS UPDRS III score
Time Frame: baseline and following 3 months of treatment
baseline and following 3 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in MDS UPDRS I, II and IV score
Time Frame: baseline and following 3 months of treatment
baseline and following 3 months of treatment
Change in Levodopa equivalent dose treatment (equivalence table)
Time Frame: baseline and following 3 months of treatment
baseline and following 3 months of treatment
Frequency, seriousness and severity of adverse event reactions
Time Frame: during the 3 months of treatment
during the 3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Collaborators

ETHNODYNE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 2, 2016

Primary Completion (ACTUAL)

March 12, 2018

Study Completion (ACTUAL)

March 12, 2018

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (ESTIMATE)

June 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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