Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine

Study Overview
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Brief Summary
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This is an observational, non-interventional and retrospective study in patients with advanced PD who have been treated with Rotigotine (Neupro®) as prescribed by physicians according to usual clinical practice in Spain. The Primary Objective will be to evaluate Non-Motor Symptoms (NMS) in advanced PD patients who have been treated with Rotigotine for at least 6 months.

Official Title
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Non-Interventional, Retrospective, Multi-center Study to Evaluate Non-Motor Symptoms in Advanced PD Patients Already Treated With Rotigotine

Conditions
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Parkinson's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible to participate in this study, all of the following criteria must be met: Male and female ambulatory patients with Parkinson's disease diagnosis (as per the London Brain Bank diagnosis criteria) ≥6 months ago Patient aged 30 years or older at the time of Parkinson's disease diagnosis Patients who were under treatment with Rotigotine following routine clinical practice, either alone or in combination with Levodopa, and in an advanced PD dosage (≥ 8 mg/ 24 h) for at least the previous 6 months Patients under treatment with Rotigotine (≥ 8 mg/ 24 h) who were assessed twice of NMS by means of the PDNMS-Q 6 months apart Patients are currently informed and have been given enough time and opportunity to think about participation (data collection) in the study and have given written informed consent Exclusion Criteria: Patients are not permitted to enroll in the study if any of the following criteria is met during the previous 6 months: Patients have other Parkinsonian syndrome different than Parkinson´s disease Patients have a history of Pallidotomy, Thalamotomy, Deep Brain Stimulation or Fetal Tissue Transplant Patients with Dementia, active Hallucinations or active or treated Psychosis Patients with any other neurological / psychological disorder Patients who had received Central Nervous System (CNS) active therapy (e.g. sedatives, hypnotics, anti-depressants, anxiolytics, atypical neuroleptics, etc)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neupro Treatment<br>Data from patients with advanced PD who have been treated with Rotigotine (Neupro®) for at least the previous 6 months as prescribed by physicians according to usual clinical practice in Spain, will be retrospectively collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Month 6 in Non-Motor Symptoms (NMS) as assessed by the Parkinson's Disease Non-Motor Symptoms Questionnaire (PDNMS-Q) |  | From Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III |  | From Baseline to Month 6 | 
| Change from Baseline to Month 6 in Hoehn & Yahr stage |  | From Baseline to Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spain, Rotigotine (Neupro), Non-Motor Symptoms, Advanced Parkinson's Disease, Local study, Observational study, Non-interventional study, Retrospective study, Post-marketing study, Multicenter study