Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-03 @ 6:16 AM
Study NCT ID:
NCT02815800
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2016-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ethnodyne Visio in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2016-06-13', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MDS UPDRS III score', 'timeFrame': 'baseline and following 3 months of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in MDS UPDRS I, II and IV score', 'timeFrame': 'baseline and following 3 months of treatment'}, {'measure': 'Change in Levodopa equivalent dose treatment (equivalence table)', 'timeFrame': 'baseline and following 3 months of treatment'}, {'measure': 'Frequency, seriousness and severity of adverse event reactions', 'timeFrame': 'during the 3 months of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment', 'Motor signs', 'Non motor signs', 'Fluctuations', 'Open labelled'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Parkinson disease (PD) with at least 3 years of evolution\n* Hoehn and Yahr score 2 or 3\n* with moderate fluctuations (score 1 or 2 for item 3 score IV MSD UPDRS)\n* with no modification in anti-parkinsonian drugs since at least 1 month\n* minimental test \\>24\n\nExclusion Criteria:\n\n* known intolerance to Ethnodyne visio\n* woman of childbearing potential or breastfeeding\n* anticipated anti-parkinsonian treatment modification during the 3 months of the study\n* antidepressant or anxiolytic drugs modified within one month prior to inclusion visit\n* other chronic disease\n* concomitant participation in a another clinical trial\n* Subject under legal guardianship'}, 'identificationModule': {'nctId': 'NCT02815800', 'acronym': 'ETHNOPARK', 'briefTitle': "Efficacy of Ethnodyne Visio in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'orgStudyIdInfo': {'id': '6312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ETHNODYNE VISIO', 'description': 'Administration 2 times a day of a dietary supplement, as add on therapy, in patients with Parkinson s disease', 'interventionNames': ['Dietary Supplement: ETHNODYNE VISIO']}], 'interventions': [{'name': 'ETHNODYNE VISIO', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['ETHNODYNE VISIO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Neurologie,Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'ETHNODYNE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}