Efficacy of Ethnodyne Visio in Parkinson's Disease

University Hospital, Strasbourg, France24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

ETHNODYNE VISIODIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de Neurologie,Hôpital de Hautepierre

Strasbourg, France

Outcomes

Primary Outcomes

Change in MDS UPDRS III score

Time frame: baseline and following 3 months of treatment

Secondary Outcomes

Change in MDS UPDRS I, II and IV score

Time frame: baseline and following 3 months of treatment

Change in Levodopa equivalent dose treatment (equivalence table)

Time frame: baseline and following 3 months of treatment

Frequency, seriousness and severity of adverse event reactions

Time frame: during the 3 months of treatment

Data from ClinicalTrials.gov

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