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
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
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
NCT ID
NCT02815800
First Posted
June 13, 2016
Last Updated
April 16, 2018
Sponsor
University Hospital, Strasbourg, France
Collaborators
ETHNODYNE
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
Learn more about this trial
Efficacy of Ethnodyne Visio in Parkinson's Disease
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