Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-30 @ 8:06 PM
Study NCT ID:
NCT04453995
Status:
UNKNOWN
Last Update Posted:
2020-07-01
First Post:
2020-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020820', 'term': 'Dyskinesias'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'every participant would be request for provide 2 ml blood for extracting the DNA sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-27', 'studyFirstSubmitDate': '2020-06-27', 'studyFirstSubmitQcDate': '2020-06-27', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the occurrence of dyskinesia and its related predicting factors', 'timeFrame': 'The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.', 'description': 'to evaluate the occurrence of dyskinesia during the 2 years of follow-up and identify its predicting factors of dyskinesia'}], 'secondaryOutcomes': [{'measure': "to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up", 'timeFrame': 'The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.', 'description': "to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson disease', 'Dyskinesia', 'follow up'], 'conditions': ['Parkinson Disease', 'Dyskinesias']}, 'descriptionModule': {'briefSummary': "Parkinson' patients who have not had dyskinesia would be observed for 2 years in a multicenter prospective study with the purposes to clarify the predicting factors of dyskinesia.", 'detailedDescription': "Parkinson' patients with daily levodopa dosage above 200mg and no dyskinesia would be recruited into the study. They would be observed for two years for analyzed the predicting factors of dyskinesia. At the baseline, demographic information, Clinical information, blood sample, picture of tongure coating would be collected at the baseline. All participants were evaluated every three months for two years. The severity of motor symptoms were evaluated every 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "a 2 years prospective study to identify the predicting factors of dyskinesia in Parkinson' patients that have received Levodopa treatment.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1) Patients have been clinically diagnosed with Parkinson disease at the recruitment.\n\n2\\) Patients have received Levodopa treatment with the daily dosage above 200mg.\n\nExclusion Criteria:\n\n* 1\\) be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have experienced dyskinesia. 3) incorporation to the investigation'}, 'identificationModule': {'nctId': 'NCT04453995', 'acronym': 'PDDIFFU', 'briefTitle': "A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': "A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'XH-19-014'}}, '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': 'There would be digital data of all the information that collected in the study. But it is still unknown that the data would be available freely'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Municipal Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': 'The Affiliated BenQ Hospital of Nanjing Medical University', 'class': 'UNKNOWN'}, {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Zhejiang Provincial Tongde Hospital', 'class': 'OTHER'}, {'name': 'Shaoxing Hospital of Traditional Chinese medicine', 'class': 'UNKNOWN'}, {'name': 'The First People Hospital of Hangzhou Lin An District', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}