Transdermal Rotigotine User Surveillance Study

Study Overview
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Brief Summary
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This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.

Detailed Description
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All patients attending the physician and fulfilling the eligibility criteria are included.

Official Title
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A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease

Conditions
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Idiopathic Parkinson Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset Exclusion Criteria: Patients who are unable to comply with study requirements
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<br>Neupro at study onset | |
| Dopamine Agonist<br>Other Dopamine-Agonist at study onset | |
| L-Dopa<br>L-Dopa | |
| Neupro + L-Dopa<br>Neupro in combination with L-Dopa at study onset | |
| Dopamine Agonist + L-Dopa<br>Other Dopamine Agonist in combination with L-Dopa at study onset | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome). | From Baseline to Visit 7 (Month 33) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. What Proportion of the waking day are dyskinesias present? Answers range from 0 (None) to 4 (76-100 % of the day). | From Baseline to Visit 7 (Month 33) | 
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question How disabling are the dyskinesias ?  Answers range from 0 (Not disabling) to 4 (Completely disabling). | From Baseline to Visit 7 (Month 33) | 
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks What proportion of the waking day is the patient off, on average? Answers range from 0 (None) to 4 (76-100 % of the day). | 33 months | 
| Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale. The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7. | 33 months | 
| Hoehn & Yahr Stage at Visit 7 (Month 33) | The Hoehn and Yahr staging of Parkinson's disease in the on stage, if applicable, had to be completed by the physician. Possible staging: 0 No signs of disease 1 Unilateral disease 2 Bilateral disease without impairment of balance 3 Mild to moderate bilateral disease, some postural instability, physically dependent 4 Severe disability, still able to walk or stand unassisted 5 Wheelchair bound or bedridden unless aided | 33 months | 
| Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine. | 33 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotigotine, Neupro