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PDDIFFU: A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT04453995
Collaborator
Shanghai Municipal Hospital of Traditional Chinese Medicine (Other), Taizhou Hospital of Zhejiang Province (Other), Second Affiliated Hospital of Soochow University (Other), The Affiliated BenQ Hospital of Nanjing Medical University (Other), The Affiliated Hospital of Qingdao University (Other), The First Affiliated Hospital with Nanjing Medical University (Other), Zhejiang Provincial Tongde Hospital (Other), Shaoxing Hospital of Traditional Chinese medicine (Other), The First People Hospital of Hangzhou Lin An District (Other)
300
Enrollment
1
Location
40.8
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease
    Actual Study Start Date :
    Jan 5, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. the occurrence of dyskinesia and its related predicting factors [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.]

      to evaluate the occurrence of dyskinesia during the 2 years of follow-up and identify its predicting factors of dyskinesia

    Secondary Outcome Measures

    1. to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up [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.]

      to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Patients have been clinically diagnosed with Parkinson disease at the recruitment.
    1. Patients have received Levodopa treatment with the daily dosage above 200mg.
    Exclusion Criteria:
      1. be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have experienced dyskinesia. 3) incorporation to the investigation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xinhua hospital affiliated to Shanghai jiaotong university school of medicine Shanghai Shanghai China 200092

    Sponsors and Collaborators

    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    • Shanghai Municipal Hospital of Traditional Chinese Medicine
    • Taizhou Hospital of Zhejiang Province
    • Second Affiliated Hospital of Soochow University
    • The Affiliated BenQ Hospital of Nanjing Medical University
    • The Affiliated Hospital of Qingdao University
    • The First Affiliated Hospital with Nanjing Medical University
    • Zhejiang Provincial Tongde Hospital
    • Shaoxing Hospital of Traditional Chinese medicine
    • The First People Hospital of Hangzhou Lin An District

    Investigators

    • Study Chair: zhenguo Liu, Ph.D., Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04453995
    Other Study ID Numbers:
    • XH-19-014
    First Posted:
    Jul 1, 2020
    Last Update Posted:
    Jul 1, 2020
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    Parkinson disease
    Dyskinesia
    follow up
    Additional relevant MeSH terms:
    Parkinson Disease
    Dyskinesias

    Study Results

    No Results Posted as of Jul 1, 2020