NCT04453995

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 1, 2020

Status Verified

December 1, 2019

Enrollment Period

3 years

First QC Date

June 27, 2020

Last Update Submit

June 27, 2020

Conditions

Keywords

Parkinson diseaseDyskinesiafollow up

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \- 1) Patients have been clinically diagnosed with Parkinson disease at the recruitment.
  • \) Patients have received Levodopa treatment with the daily dosage above 200mg.

You may not qualify if:

  • \) be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have experienced dyskinesia. 3) incorporation to the investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua hospital affiliated to Shanghai jiaotong university school of medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

every participant would be request for provide 2 ml blood for extracting the DNA sample

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • zhenguo Liu, Ph.D.

    Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2020

First Posted

July 1, 2020

Study Start

January 5, 2019

Primary Completion

December 31, 2021

Study Completion

June 1, 2022

Last Updated

July 1, 2020

Record last verified: 2019-12

Locations