Efficacy of Ethnodyne Visio in Parkinson's Disease

NCT02815800 | Completed

• 1 other identifier: 6312
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Treatment; Motor signs; Non motor signs; Fluctuations; Open labelled

Outcome Measures

Primary Outcomes (1)

• Change in MDS UPDRS III score

  baseline and following 3 months of treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

ETHNODYNE VISIO

EXPERIMENTAL

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

Dietary Supplement: ETHNODYNE VISIO

Interventions

ETHNODYNE VISIO DIETARY_SUPPLEMENT

ETHNODYNE VISIO

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• known intolerance to Ethnodyne visio
• woman of childbearing potential or breastfeeding
• anticipated anti-parkinsonian treatment modification during the 3 months of the study
• other chronic disease
• concomitant participation in a another clinical trial
• Subject under legal guardianship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• ETHNODYNE: collaborator

Study Sites (1)

Service de Neurologie,Hôpital de Hautepierre

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 28, 2016
• Study Start: September 2, 2016
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)