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A multi-country, Observational, cross-sectional study to characterise advanced Parkinson’s Disease patients in Movement Disorder Centres.

Observational study aimed at understanding the proportion and patient characteristics of advanced Parkinson’s Disease patients in movement disorder centres in different countries and to evaluate any regional differences.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000477527
Acronym
OBSERVE-PD
Enrollment
2632
Registered
2015-05-14
Start date
2015-02-08
Completion date
2016-01-14
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This multi-country, observational study will primarily determine the proportion of PD patients treated at Movement Disorder Centers (MDC), who are identified as advanced PD patients. This study will also compare the proportion of PD patients identified as “advanced” based on routine clinical practice (physician’s judgement) to the proportion of “advanced” patients identified based on a set of consensus criteria generated by Delphi method. The main purpose of this study is to enhance the understanding of the proportion and patient characteristics of advanced PD patients in Movement Disorder Centers in different regions and to evaluate any regional differences.

Interventions

This non-interventional, observational study will be conducted in a cross-sectional format. The study population will consist of adult patients diagnosed with Parkinson’s Disease, who are attending a routine clinical visit or are inpatients at the participating clinical sites in the country of interest. In order to avoid selection bias, patients will be asked for interest and enrolled in the study consecutively in each study site. Each patient will have one assessment (study visit) only, at whic

This non-interventional, observational study will be conducted in a cross-sectional format. The study population will consist of adult patients diagnosed with Parkinson’s Disease, who are attending a routine clinical visit or are inpatients at the participating clinical sites in the country of interest. In order to avoid selection bias, patients will be asked for interest and enrolled in the study consecutively in each study site. Each patient will have one assessment (study visit) only, at which all data will be collected. Data collected during the study visit consists of data from patients medical records including patient demographics, PD related data, PD treatment (past and present) and co-morbidites. The following assessment scales will be used by the researcher: (1) Unified Parkinson´s Disease Rating Scale (UPDRS) part II-IV for evaluation of activities of daily living, motor functions, complications of therapy (dyskinesia), (2) UPDRS part V, Modified Hoehn and Yahr Staging for PD symptoms, progress and relative level of disability and (3) Non-Motor Symptom Assessment Scale for Parkinson’s Disease (NMSS) for evaluation of non-motor symptoms. The researcher will also assess whether the patient fulfils some predefined advanced PD criteria. One patient questionnaire, Parkinson’s disease Quality of Life Questionnaire (PDQ-8) will be administered to collect information on patient quality of life. Estimated time for the whole visit is approximately one hour.

Sponsors

AbbVie
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Consecutive Parkinson’s Disease patients attending a routine visit at a participating clinic and who fulfil the following selection criteria can be included: -adult male or female -diagnosis of Parkinson’s Disease -willingness to sign and date a Patient Authorization Form to use and disclose personal health information (or informed consent form if required) -being able to speak the language of the provided patient questionnaire.

Exclusion criteria

-Patients in the ‘off’ stage at the time of the visit -Participation in a concurrent clinical study -Significant uncertainty around the diagnosis of Parkinson’s Disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026