Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.

Official Title
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Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Mirapex LA


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included. Exclusion criteria: - None
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 |
| --- | --- |
| Patient with Parkinson's Disease<br> | Drug: Mirapex LA<br>* Pramipexole Hydrochloride Hydrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Adverse Drug Reactions | Percentage of subjects with adverse drug reactions | From baseline up to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Effect | Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect. | Week 52 | 
| Change From Baseline in Total Score of the UPDRS Part III to Last Observation | Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score. UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status. The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities. The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia. | Baseline and week 52 | 
| Change From Baseline in the Modified Hoehn & Yahr to Last Observation | Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement. | Baseline and week 52 | 
| Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - on - to a sudden inability to move - off. | Week 52 | 
| Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA | Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication. | Week 52 |