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

Boehringer Ingelheim2,017 enrolled

Overview

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.

Purpose:

Study Type

OBSERVATIONAL

Enrollment

2,017

Conditions

Parkinson Disease

Interventions

pramipexoleDRUG

as prescibed by the investigator

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria 2. Age: from 30 to 75 years old 3. Stage I-IV of revised Hoehn-Yahr standards 4. With current use of pramipexole 5. Informed consent signed by every subject Exclusion criteria: 1. Diagnosis of Parkinson¿s syndrome 2. Current use of psychotolytic medications 3. Allergic to pramipexole or any other ingredient of pramipexole 4. Female patients in pregnancy and lactation 5. 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

Locations (103)

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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Boehringer Ingelheim Investigational Site 54

Beijing, China

Boehringer Ingelheim Investigational Site 55

Beijing, China

Boehringer Ingelheim Investigational Site 56

Beijing, China

Boehringer Ingelheim Investigational Site 57

Beijing, China

Boehringer Ingelheim Investigational Site 58

Beijing, China

Boehringer Ingelheim Investigational Site 59

Beijing, China

Boehringer Ingelheim Investigational Site 60

Beijing, China

Boehringer Ingelheim Investigational Site 61

Beijing, China

Boehringer Ingelheim Investigational Site 62

Beijing, China

Boehringer Ingelheim Investigational Site 63

Beijing, China

...and 93 more locations