Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

Study Overview
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Brief Summary
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The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.

Official Title
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Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's disease with or without fluctuations Indication for treatment with pramipexole (Mirapexin®) Presence of at least mild tremor symptoms (as judged by the treating physician) Exclusion Criteria: Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients. Ongoing treatment with pramipexole (Mirapexin®)
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 |
| --- | --- |
| Patients with Parkinson's disease<br>Early and advanced Parkinson's disease patients | |

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 II Score at the End of Maintenance | Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability) | Week 0 to weeks 9-16 (Visit 3) | 
| Change From Baseline in UPDRS Part III Score at the End of Maintenance | Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability) | Week 0 to weeks 9-16 | 
| Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand) | Change (reduction) in tremor amplitude from baseline to end of study for the right hand | Week 0 to weeks 9-16 (Visit 3) | 
| Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand) | Change (reduction) in tremor amplitude from baseline to end of study for the left hand | Week 0 to weeks 9-16 (Visit 3) | 
| Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3) | Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor) | Week 0 to weeks 9-16 (Visit 3) | 
| Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance | Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure) | Week 0 to weeks 9-16 (Visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final Dose Distribution | Final Mirapexin® dose distribution at the end of study | Enter Week 0 to weeks 9-16 (Visit 3) | 
| Change From Baseline in UPDRS Part II Score at the End of Up-titration | Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability) | Enter Week 0 to weeks 1-8 (Visit 2) | 
| Change From Baseline in UPDRS Part III Score at the End of Up-titration | Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability) | Enter Week 0 to weeks 1-8 (Visit 2) | 
| Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration | Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor) | Enter Week 0 to weeks 1-8 (Visit 2) | 
| Incidence, Relationship and Seriousness of Adverse Events | Total number of adverse events (AEs), causality and level of seriousness | Week 0 to weeks 9-16 (end of study) | 
| Number of Premature Discontinuations | Number of patients discontinuing the study prematurely | Week 0 to weeks 9-16 (end of study) |