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

• Conditions: Parkinson Disease; Dyskinesias

• Registration Number: NCT04453995
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

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 Timeline

• Study Start: 2019-01-05
• Status Verified: 2019-12
• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-06-27
• Last Update Submitted: 2020-06-27
• Study First Posted: 2020-07-01
• Last Update Posted: 2020-07-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Xinhua hospital affiliated to Shanghai jiaotong university school of medicine; 🇨🇳 Shanghai, Shanghai, China