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

Parkinson Disease Clinical Trial

— PDDIFFU  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04453995
• Other study ID #: XH-19-014
• Status: Active, not recruiting
• Start date: January 5, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Locations

Country	Name	City	State
China	Xinhua hospital affiliated to Shanghai jiaotong university school of medicine	Shanghai	Shanghai

Sponsors (10)

Lead Sponsor

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Second Affiliated Hospital of Soochow University, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shaoxing Hospital of Traditional Chinese medicine, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Affiliated BenQ Hospital of Nanjing Medical University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital with Nanjing Medical University, The First People Hospital of Hangzhou Lin An District, Zhejiang Provincial Tongde Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.