Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-03-05 @ 9:49 AM
Study NCT ID:
NCT03792204
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2018-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Prevalence of "Wearing-off" in Patients With Parkinson's Disease in Shanghai
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-01', 'studyFirstSubmitDate': '2018-07-22', 'studyFirstSubmitQcDate': '2019-01-01', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China", 'timeFrame': '1 year', 'description': 'every participant receives a clinical assessment of the wearing-off symptoms by a physician and completes a self rating scale of the wearing-off 9 questionnaire (WOQ-9) to obtain a prevalence of wearing-off positive individuals( wearing-off would be diagnosed by physicians during the clinical assessments)'}], 'secondaryOutcomes': [{'measure': "the sensitivity and the specificity of the wearing-off 9 questionnaire in the diagnosis of wearing-off effect in Parkinson's disease.", 'timeFrame': '1 year', 'description': 'The physician assessment served as the standard for comparison with the WOQ-9 questionnaire. Sensitivity was defined as the probability that a PD patient, classified as having wearing-off (WO) according to physician assessment, would be classified as having the WO using the WOQ-9 questionnaire. The specificity was defined as the probability that a PD patient without the WO by physician assessments would be classified as being without the WO using the WOQ-9 questionnaire'}, {'measure': 'the risk factors of wearing-off in Parkinson disease', 'timeFrame': '1 year', 'description': 'assess patients clinical characteristics and medical treatments, including the onset age, disease duration and daily levodopa dosage in the subsets of Parkinson patients with wearing-off diagnosed by physician assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wearing off', 'wearing-off 9 questionnaire', 'prevalence', 'sensitivity', 'specificity'], 'conditions': ['Wearing Off Effect', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The study would be designed as a multi-center cross-sectional investigation on the prevalence of Wearing-off in Parkinson's patients in Shanghai as well as related influencing factors.", 'detailedDescription': 'PD patients would be randomly recruited into this investigation from around thirty hospital covering the 16 districts of Shanghai. The wearing off would be defined by two methods: the doctors\' judgement or the WOQ-9 questionnaire which was a patient-determining tool. The investigation also includes the medicine, the severity of PD symptoms, the demographic factors. The study would be designed with the purpose of clarifying the prevalence of the "wearing-off" and its related influencing factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'clinical diagnosed PD patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* have been clinical diagnosed with Parkinson's disease\n* have received stable anti-Parkinson's treatment before being recruited to the study.\n\nExclusion Criteria:\n\n* being suspicious of atypical Parkinson syndrome or secondary Parkinson syndromes\n* have not received anti Parkinsonian treatment.\n* being combined with serious cognitive dysfunction or psychiatric symptoms\n* unable to complete the investigations."}, 'identificationModule': {'nctId': 'NCT03792204', 'acronym': 'shapd-woq', 'briefTitle': 'the Prevalence of "Wearing-off" in Patients With Parkinson\'s Disease in Shanghai', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'the Prevalence of "Wearing-off" in Patients With Parkinson\'s Disease in Shanghai, China: a Cross-sectional Investigation', 'orgStudyIdInfo': {'id': 'XH-18-011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD patients with wearing-off effect', 'description': "people who have been clinically diagnosed with Parkinson's disease (PD) and have received anti PD therapy would be recruited into the study. The anti -PD treatment would not be changed in the population of the participants.\n\nWe would use the tool of 'Wearing-off 9 questionnaire' to determine the prevalence of Wearing-off phenomenon in Parkinson's patients in Shanghai", 'interventionNames': ['Diagnostic Test: Wearing-off 9 questionnaire']}], 'interventions': [{'name': 'Wearing-off 9 questionnaire', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['No other intervention'], 'description': "The participants would receive appropriate anti-PD medical treatments according to the patients' need during the investigation.The anti -PD treatment would not be changed in the population of the participants.", 'armGroupLabels': ['PD patients with wearing-off effect']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xinhua hospital affiliated to Shanghai jiaotong university school of medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhenguo Liu, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided to make individual participant data available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}