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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ETHNODYNE VISIO
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring Treatment, Motor signs, Non motor signs, Fluctuations, Open labelled

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Neurologie,Hôpital de Hautepierre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ETHNODYNE VISIO

Arm Description

Administration 2 times a day of a dietary supplement, as add on therapy, in patients with Parkinson s disease

Outcomes

Primary Outcome Measures

Change in MDS UPDRS III score

Secondary Outcome Measures

Change in MDS UPDRS I, II and IV score
Change in Levodopa equivalent dose treatment (equivalence table)
Frequency, seriousness and severity of adverse event reactions

Full Information

First Posted
June 13, 2016
Last Updated
April 16, 2018
Sponsor
University Hospital, Strasbourg, France
Collaborators
ETHNODYNE
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1. Study Identification

Unique Protocol Identification Number
NCT02815800
Brief Title
Efficacy of Ethnodyne Visio in Parkinson's Disease
Acronym
ETHNOPARK
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2, 2016 (Actual)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
ETHNODYNE

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Treatment, Motor signs, Non motor signs, Fluctuations, Open labelled

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ETHNODYNE VISIO
Arm Type
Experimental
Arm Description
Administration 2 times a day of a dietary supplement, as add on therapy, in patients with Parkinson s disease
Intervention Type
Dietary Supplement
Intervention Name(s)
ETHNODYNE VISIO
Primary Outcome Measure Information:
Title
Change in MDS UPDRS III score
Time Frame
baseline and following 3 months of treatment
Secondary Outcome Measure Information:
Title
Change in MDS UPDRS I, II and IV score
Time Frame
baseline and following 3 months of treatment
Title
Change in Levodopa equivalent dose treatment (equivalence table)
Time Frame
baseline and following 3 months of treatment
Title
Frequency, seriousness and severity of adverse event reactions
Time Frame
during the 3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Neurologie,Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Ethnodyne Visio in Parkinson's Disease

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