a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients

Study Overview
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Brief Summary
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This is an open-label, multicenter, non-interventional, prospective observational study. we collect the safety information of pramipexole over 12w treatment. Parkinson disease patients with different severity who have already used pramipexole could be observed in this study. In the whole observation period, treatment decision was determined by physician and patient completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient withdraw, laboratory test.

Detailed Description
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Purpose:

Official Title
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Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: pramipexole


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria Age: from 30 to 75 years old Stage I-IV of revised Hoehn-Yahr standards With current use of pramipexole Informed consent signed by every subject Exclusion criteria: Diagnosis of Parkinson¿s syndrome Current use of psychotolytic medications Allergic to pramipexole or any other ingredient of pramipexole Female patients in pregnancy and lactation Patients who were participating in other clinical studies by signing relevant informed consent or who received other investigational drugs within 30 days prior to the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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 |
| --- | --- |
| pramipexole group<br>It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world. | Drug: pramipexole<br>* as prescibed by the investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AE/SAE | The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) | Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor). | Baseline (Visit 1) and 12 weeks (Visit 3) | 
| The Dosage Related Information of Pramipexole at Baseline | At enrollment, the distribution of patients in 3 pramipexole dosage categories. | baseline | 
| The Dosage Related Information of Pramipexole at the End of Study | At the end of study, the distribution of patients in 3 pramipexole dosage categories. | 12 weeks |