Efficacy of Ethnodyne Visio in Parkinson's Disease | NCT02815800

Studies
Efficacy of Ethnodyne Visio in Parkinson's Disease

NCT02815800

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Apr 18, 2018Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Parkinson's Disease

Interventions

ETHNODYNE VISIO

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2016Actual

Primary Completion Date

Mar 12, 2018Actual

Completion Date

Mar 12, 2018Actual

First Submitted Date

Jun 13, 2016

First Submission Date that Met QC Criteria

Jun 27, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 18, 2018Actual

Name	Class
ETHNODYNE	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ETHNODYNE VISIO	Dietary Supplement		ETHNODYNE VISIO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in MDS UPDRS III score		baseline and following 3 months of treatment

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Neurologie,Hôpital de Hautepierre		Strasbourg		67098	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided