Parkinson's DiseaseETHNOPARKNCT02815800
Efficacy of Ethnodyne Visio in Parkinson's Disease
A study testing ETHNODYNE VISIO in people with Parkinson's Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ETHNODYNE VISIO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2016to 12 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ETHNODYNE VISIO
- Keywords
- Treatment, Motor signs, Non motor signs, Fluctuations, Open labelled
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETHNODYNE VISIODietary supplement
| Study group | Role | What they receive |
|---|---|---|
| ETHNODYNE VISIO | Experimental | Administration 2 times a day of a dietary supplement, as add on therapy, in patients with Parkinson s disease Receives: Dietary Supplement: ETHNODYNE VISIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MDS UPDRS III score
Measured: baseline and following 3 months of treatment
Secondary outcomes (3)
Change in MDS UPDRS I, II and IV score
Measured: baseline and following 3 months of treatment
Change in Levodopa equivalent dose treatment (equivalence table)
Measured: baseline and following 3 months of treatment
Frequency, seriousness and severity of adverse event reactions
Measured: during the 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start2 Sep 2016
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- ETHNODYNE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815800
- Sponsor's protocol ID
- 6312
- Acronym
- ETHNOPARK
- Status last verified
- Apr 2018
- First submitted
- 13 Jun 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ethnodyne Visio in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02815800
- Acronym / sponsor ID
- ETHNOPARK / 6312
- Conditions
- Parkinson's Disease
- Keywords
- Treatment, Motor signs, Non motor signs, Fluctuations, Open labelled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- ETHNODYNE
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ETHNODYNE VISIO | Experimental | Dietary Supplement: ETHNODYNE VISIOAdministration 2 times a day of a dietary supplement, as add on therapy, in patients with Parkinson s disease |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETHNODYNE VISIO | Dietary supplement | ETHNODYNE VISIO |
Primary outcome
Change in MDS UPDRS III score
Time frame: baseline and following 3 months of treatment
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETHNODYNE VISIO in people with Parkinson's Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MDS UPDRS III score (time frame: baseline and following 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.