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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease; Dyskinesias

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

a 2 years prospective study to identify the predicting factors of dyskinesia in Parkinson' patients that have received Levodopa treatment.

Description

Inclusion Criteria:

- 1) Patients have been clinically diagnosed with Parkinson disease at the recruitment.

2) 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the occurrence of dyskinesia and its related predicting factors	to evaluate the occurrence of dyskinesia during the 2 years of follow-up and identify its predicting factors of dyskinesia	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2019
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: June 27, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 27, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Parkinson disease; follow up; Dyskinesia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dyskinesias
• Other Study ID Numbers: XH-19-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No