Clinical trial NCT04453995: A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease
Official title: A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Dyskinesias
Keywords: Parkinson disease
Dyskinesia
follow up
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Second Affiliated Hospital of Soochow University
name: The Affiliated BenQ Hospital of Nanjing Medical University
name: The Affiliated Hospital of Qingdao University
name: The First Affiliated Hospital with Nanjing Medical University
name: Zhejiang Provincial Tongde Hospital
name: Shaoxing Hospital of Traditional Chinese medicine
name: The First People Hospital of Hangzhou Lin An District
First posted: 2020-07-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the occurrence of dyskinesia and its related predicting factors
timeFrame: 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 outcomes:
measure: to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up
timeFrame: 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.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua hospital affiliated to Shanghai jiaotong university school of medicine
state: Shanghai
Study officials:
affiliation: Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine
name: zhenguo Liu, Ph.D.
role: STUDY_CHAIR
References: