NCT04957420

Brief Summary

This is a multicenter, prospective, non intervention post marketing surveillance study conducted in Chinese mainland. The main objective was to evaluate the safety characteristics of rotigotine patch in the treatment of Chinese adult patients with idiopathic Parkinson's disease in real world clinical practice.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 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

First Submitted

Initial submission to the registry

June 27, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 27, 2021

Last Update Submit

July 8, 2021

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • (serious) adverse events (AE) and (serious) adverse drug reactions (ADRs)

    (serious) adverse events (AE) and (serious) adverse drug reactions (ADRs)

    in 12 weeks

Study Arms (1)

Neupro gruop

Patients using Neupro according to the standard clinical practice of therapists

Drug: Neupro

Interventions

NeuproDRUG

Rotigotine Patches

Neupro gruop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient was diagnosed as idiopathic Parkinson's disease

You may qualify if:

  • Patients must meet the following selection criteria to enter the non intervention study:
  • The decision of the treatment doctor to prescribe rotigotine patch has nothing to do with whether to participate in the non intervention study.
  • The patient or his legal representative can understand the informed consent of the patient data.
  • The informed consent form of patient data shall be signed and dated by the patient or his legal representative.
  • The patient is over 18 years old.
  • The patient was diagnosed as idiopathic Parkinson's disease

You may not qualify if:

  • Patients meeting any of the following criteria should be excluded from the study:
  • For any reason, the researcher (therapist) thinks that the patient is not suitable to participate in this study.
  • Patients had received rotigotine patch for more than 4 weeks before study enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijin, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 12, 2021

Study Start

July 1, 2021

Primary Completion

December 31, 2021

Study Completion

April 30, 2022

Last Updated

July 12, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)