Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

Study Overview
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Brief Summary
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The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.

Official Title
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Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

Conditions
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Parkinson's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Early and advanced idiopathic Parkinson's disease Male and female patients over 18 years of age Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC) Exclusion criteria: Ongoing treatment with pramipexole ER Exclusion criteria in line with the pramipexole ER SmPC: In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Male and female patients with Parkinson's disease<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | The number of patients with any adverse events (AEs), patients with drug-related AEs. | From the treatment initiation to the end of study, on average 92.9 days | 
| Proportion of Patients With Withdrawals Due to Adverse Events. | Patients who discontinued treatment due to adverse events including deaths. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score | Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement. | Baseline and the end of study (up to 16 weeks) | 
| Clinical Global Impression of Improvement (CGI-I) Responder Rate | The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved. | Baseline and the end of study (up to 16 weeks) | 
| Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction | The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction. | Baseline and the end of study (up to 16 weeks) | 
| Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score | The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement | Baseline and the end of study (up to 16 weeks) |