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CompletedNCT03792204shapd-woqUpdated Jan 3, 2019

the Prevalence of "Wearing-off" in Patients With Parkinson's Disease in Shanghai

An observational study in Wearing Off Effect and Parkinson Disease, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 35 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-01-03.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
1,480
Ages
35 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

PD patients would be randomly recruited into this investigation from around thirty hospital covering the 16 districts of Shanghai. The wearing off would be defined by two methods: the doctors' judgement or the WOQ-9 questionnaire which was a patient-determining tool. The investigation also includes the medicine, the severity of PD symptoms, the demographic factors. The study would be designed with the purpose of clarifying the prevalence of the "wearing-off" and its related influencing factors.

02

Conditions studied

  • Wearing Off Effect
  • Parkinson Disease

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Keywords

  • wearing off
  • wearing-off 9 questionnaire
  • prevalence
  • sensitivity
  • specificity
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 1,480 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

clinical diagnosed PD patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
1,480 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testWearing-off 9 questionnaire

    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

06

What researchers measure

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)

    Time frame: 1 year

Secondary outcomes

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

    The physician assessment served as the standard for comparison with the WOQ-9 questionnaire. Sensitivity was defined as the probability that a PD patient, classified as having wearing-off (WO) according to physician assessment, would be classified as having the WO using the WOQ-9 questionnaire. The specificity was defined as the probability that a PD patient without the WO by physician assessments would be classified as being without the WO using the WOQ-9 questionnaire

    Time frame: 1 year

  2. the risk factors of wearing-off in Parkinson disease

    assess patients clinical characteristics and medical treatments, including the onset age, disease duration and daily levodopa dosage in the subsets of Parkinson patients with wearing-off diagnosed by physician assessment.

    Time frame: 1 year

07

Study locations

1 site
  • Xinhua hospital affiliated to Shanghai jiaotong university school of medicine
    Shanghai, Shanghai 200092, China
08

References and documents

Individual participant data

Plan to share: Undecided — Undecided to make individual participant data available to other researchers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03792204
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Sponsor
First posted
Jan 3, 2019
Start date
Sep 1, 2017
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Jan 3, 2019

Study contacts

Zhenguo Liu, Ph.D.
study chair · Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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