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NCT Number: NCT02815800

Efficacy of Ethnodyne Visio in Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie,Hôpital de Hautepierre

Strasbourg, 67098, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETHNODYNE VISIO

Dietary Supplement

Primary outcomes

  1. Change in MDS UPDRS III score

    Time frame: baseline and following 3 months of treatment

Secondary outcomes

  1. Change in MDS UPDRS I, II and IV score

    Time frame: baseline and following 3 months of treatment

  2. Change in Levodopa equivalent dose treatment (equivalence table)

    Time frame: baseline and following 3 months of treatment

  3. Frequency, seriousness and severity of adverse event reactions

    Time frame: during the 3 months of treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Collaborators

  • ETHNODYNE

Registry information

Acronym: ETHNOPARK

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2016
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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