Parkinson's Disease
Conditions
Keywords
Treatment, Motor signs, Non motor signs, Fluctuations, Open labelled
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MDS UPDRS III score | baseline and following 3 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in MDS UPDRS I, II and IV score | baseline and following 3 months of treatment |
| Change in Levodopa equivalent dose treatment (equivalence table) | baseline and following 3 months of treatment |
| Frequency, seriousness and severity of adverse event reactions | during the 3 months of treatment |
Countries
France