NCT03792204

Brief Summary

The study would be designed as a multi-center cross-sectional investigation on the prevalence of Wearing-off in Parkinson's patients in Shanghai as well as related influencing factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
Last Updated

January 3, 2019

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

July 22, 2018

Last Update Submit

January 1, 2019

Conditions

Keywords

wearing offwearing-off 9 questionnaireprevalencesensitivityspecificity

Outcome Measures

Primary Outcomes (1)

  • the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China

    every participant receives a clinical assessment of the wearing-off symptoms by a physician and completes a self rating scale of the wearing-off 9 questionnaire (WOQ-9) to obtain a prevalence of wearing-off positive individuals( wearing-off would be diagnosed by physicians during the clinical assessments)

    1 year

Secondary Outcomes (2)

  • the sensitivity and the specificity of the wearing-off 9 questionnaire in the diagnosis of wearing-off effect in Parkinson's disease.

    1 year

  • the risk factors of wearing-off in Parkinson disease

    1 year

Study Arms (1)

PD patients with wearing-off effect

people who have been clinically diagnosed with Parkinson's disease (PD) and have received anti PD therapy would be recruited into the study. The anti -PD treatment would not be changed in the population of the participants. We would use the tool of 'Wearing-off 9 questionnaire' to determine the prevalence of Wearing-off phenomenon in Parkinson's patients in Shanghai

Diagnostic Test: Wearing-off 9 questionnaire

Interventions

The participants would receive appropriate anti-PD medical treatments according to the patients' need during the investigation.The anti -PD treatment would not be changed in the population of the participants.

Also known as: No other intervention
PD patients with wearing-off effect

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

clinical diagnosed PD patients

You may qualify if:

  • have been clinical diagnosed with Parkinson's disease
  • have received stable anti-Parkinson's treatment before being recruited to the study.

You may not qualify if:

  • being suspicious of atypical Parkinson syndrome or secondary Parkinson syndromes
  • have not received anti Parkinsonian treatment.
  • being combined with serious cognitive dysfunction or psychiatric symptoms
  • unable to complete the investigations.

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

MeSH Terms

Conditions

Parkinson DiseaseHypersensitivity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesImmune System Diseases

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
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2018

First Posted

January 3, 2019

Study Start

September 1, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

January 3, 2019

Record last verified: 2018-07

Locations