<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453995</url>
  </required_header>
  <id_info>
    <org_study_id>XH-19-014</org_study_id>
    <nct_id>NCT04453995</nct_id>
  </id_info>
  <brief_title>A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease</brief_title>
  <acronym>PDDIFFU</acronym>
  <official_title>A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Municipal Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated BenQ Hospital of Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Qingdao University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Provincial Tongde Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaoxing Hospital of Traditional Chinese medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First People Hospital of Hangzhou Lin An District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson' patients who have not had dyskinesia would be observed for 2 years in a&#xD;
      multicenter prospective study with the purposes to clarify the predicting factors of&#xD;
      dyskinesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson' patients with daily levodopa dosage above 200mg and no dyskinesia would be&#xD;
      recruited into the study. They would be observed for two years for analyzed the predicting&#xD;
      factors of dyskinesia. At the baseline, demographic information, Clinical information, blood&#xD;
      sample, picture of tongure coating would be collected at the baseline. All participants were&#xD;
      evaluated every three months for two years. The severity of motor symptoms were evaluated&#xD;
      every 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 5, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the occurrence of dyskinesia and its related predicting factors</measure>
    <time_frame>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.</time_frame>
    <description>to evaluate the occurrence of dyskinesia during the 2 years of follow-up and identify its predicting factors of dyskinesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up</measure>
    <time_frame>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.</time_frame>
    <description>to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Dyskinesias</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      every participant would be request for provide 2 ml blood for extracting the DNA sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        a 2 years prospective study to identify the predicting factors of dyskinesia in Parkinson'&#xD;
        patients that have received Levodopa treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 1) Patients have been clinically diagnosed with Parkinson disease at the recruitment.&#xD;
&#xD;
        2) Patients have received Levodopa treatment with the daily dosage above 200mg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have&#xD;
             experienced dyskinesia. 3) incorporation to the investigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zhenguo Liu, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xinhua hospital affiliated to Shanghai jiaotong university school of medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 27, 2020</last_update_submitted>
  <last_update_submitted_qc>June 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson disease</keyword>
  <keyword>Dyskinesia</keyword>
  <keyword>follow up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dyskinesias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453995
org study id: XH-19-014
nct id: NCT04453995
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: the occurrence of dyskinesia and its related predicting factors
time frame: 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
measure: to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up
time frame: 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
every participant would be request for provide 2 ml blood for extracting the DNA sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: zhenguo Liu, Ph.D.
role: Study Chair
affiliation: Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dyskinesias
sharing ipd: Undecided
ipd 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