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

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
pramipexole group	pramipexole	It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Dosage Related Information of Pramipexole at Baseline	baseline	At enrollment, the distribution of patients in 3 pramipexole dosage categories.
Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)	Baseline (Visit 1) and 12 weeks (Visit 3)	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).
The Dosage Related Information of Pramipexole at the End of Study	12 weeks	At the end of study, the distribution of patients in 3 pramipexole dosage categories.

Locations (103): Boehringer Ingelheim Investigational Site 54
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Beijing, China
Boehringer Ingelheim Investigational Site 55
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Beijing, China
Boehringer Ingelheim Investigational Site 56
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Beijing, China
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Beijing, China
Boehringer Ingelheim Investigational Site 58
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Beijing, China
Boehringer Ingelheim Investigational Site 59
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Beijing, China
Boehringer Ingelheim Investigational Site 60
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Beijing, China
Boehringer Ingelheim Investigational Site 61
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Beijing, China
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Beijing, China
Boehringer Ingelheim Investigational Site 63
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Beijing, China
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Boehringer Ingelheim Investigational Site 54
🇨🇳Beijing, China