Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-05 @ 12:07 AM
Study NCT ID:
NCT02859805
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-04', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '2 years', 'description': 'Self questionnaires with Beck Depression Scale'}, {'measure': 'Quality of life', 'timeFrame': '2 years', 'description': "use of measurement scales Quality of Life; PDQ-39 it's a 39-item Parkinson's disease questionnaire (Record socio-demographic information)"}], 'secondaryOutcomes': [{'measure': 'Socio-demographic data', 'timeFrame': '2 years', 'description': 'age, sex, socioeconomic status,'}, {'measure': 'clinical evaluation', 'timeFrame': '2 years', 'description': 'clinical form of the disease'}, {'measure': 'clinical evaluation', 'timeFrame': '2 years', 'description': 'current treatments and comorbidities'}, {'measure': 'clinical evaluation', 'timeFrame': '2 years', 'description': "Questionnaire administered hetero Q1, Early questionnaire and UPDRS (Unified Parkinson's Disease Rating Scale)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to validate a diagnostic tool severity of these common non-motor manifestations, disturbing and little recognized as a self-questionnaire. This assessment tool used on different subgroups of patients (free from any treatment at an early stage of the disease and the stage of motor complications) will better understand the natural history of the non-motor fluctuations (FNM)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "patient suffering from Parkinson's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient aged 30 or over Patient having an Parkinson's disease Patient hospitalized in one of the clinical sites participating in the project Patient have agreed to participate in the study subject that masters the French language and able to fulfill the self-questionnaire.\n\nExclusion Criteria:\n\nPatient aged under 30 Patient can not answer the self-administered questionnaire Patient has not agreed to participate in the study."}, 'identificationModule': {'nctId': 'NCT02859805', 'briefTitle': "Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': "Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient", 'orgStudyIdInfo': {'id': 'RC12_3341 - 1726'}}, 'armsInterventionsModule': {'interventions': [{'name': 'validation of a diagnostic tool severity of non-motor symptoms in Parkinson patients', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Urielle DESALBRES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique des Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}