Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch

Study Overview
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Brief Summary
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The study intends to collect data on gastrointestinal symptoms (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient satisfaction under everyday practice conditions after changing treatment to Neupro® transdermal patch in patients suffering from idiopathic Parkinson´s Disease with gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide any relief in gastrointestinal symptoms.

Detailed Description
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Routine treatment as per approved label in Europe in accordance with the terms of the local marketing authorization for Neupro®.

Official Title
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A Multicentric, Non-interventional Study on Switching From Oral Parkinson Therapy to Neupro® in Patients With Idiopathic Parkinson's Disease With Gastrointestinal Symptoms

Conditions
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Idiopathic Parkinson's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The decision to prescribe Neupro® must have been made by the physician before and independently of his/her decision to include the patient in the study The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro® The patient must have a diagnosis of Idiopathic Parkinson's disease The patient must have signed the Consent form regarding study information, data transfer and use Patient suffering from gastrointestinal symptoms while being treated with oral Parkinson's medication Exclusion Criteria: Not applicable
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>Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS) | Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement. | From Baseline to Visit 3 (approximately 6 weeks) | 
| Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints | Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day). For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12). Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement. | From Baseline to Visit 3 (approximately 6 weeks) | 
| Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | Patient satisfaction referring to GI complaints is classified into 5 categories: Missing Very satisfied Satisfied Moderately satisfied Not satisfied. | At Visit 2 (after approximately 2-4 weeks) | 
| Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | Patient satisfaction referring to GI complaints is classified into 5 categories: Missing Very satisfied Satisfied Moderately satisfied Not satisfied. | At Visit 3 (after approximately 6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotigotine, Neupro®, Parkinson's disease, Gastrointestinal, Switch from oral therapy to patch