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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: pramipexole

Detailed Description

Purpose:

• Study Type: Observational
• Enrollment (Actual): 2017

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • 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
    • Boehringer Ingelheim Investigational Site 64
  • Beijing, China
    • Boehringer Ingelheim Investigational Site 65
  • Changchun, China
    • Boehringer Ingelheim Investigational Site 66
  • Changchun, China
    • Boehringer Ingelheim Investigational Site 67
  • Changsh, China
    • Boehringer Ingelheim Investigational Site 12
  • Changsh, China
    • Boehringer Ingelheim Investigational Site 13
  • Changsh, China
    • Boehringer Ingelheim Investigational Site 14
  • Changsh, China
    • Boehringer Ingelheim Investigational Site 15
  • Changsh, China
    • Boehringer Ingelheim Investigational Site 16
  • Chendu, China
    • Boehringer Ingelheim Investigational Site 94
  • Chendu, China
    • Boehringer Ingelheim Investigational Site 95
  • Chongqing, China
    • Boehringer Ingelheim Investigational Site 100
  • Chongqing, China
    • Boehringer Ingelheim Investigational Site 101
  • Chongqing, China
    • Boehringer Ingelheim Investigational Site 97
  • Chongqing, China
    • Boehringer Ingelheim Investigational Site 98
  • Chongqing, China
    • Boehringer Ingelheim Investigational Site 99
  • Dalian, China
    • Boehringer Ingelheim Investigational Site 71
  • Dalian, China
    • Boehringer Ingelheim Investigational Site 72
  • Daqing, China
    • Boehringer Ingelheim Investigational Site 79
  • Fuzhou, China
    • Boehringer Ingelheim Investigational Site 35
  • Fuzhou, China
    • Boehringer Ingelheim Investigational Site 36
  • Fuzhou, China
    • Boehringer Ingelheim Investigational Site 37
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 80
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 81
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 82
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 83
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 84
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 85
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 86
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 87
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 88
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 89
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 90
  • Guangzhou, China
    • Boehringer Ingelheim Investigational Site 91
  • Haerbin, China
    • Boehringer Ingelheim Investigational Site 77
  • Haerbin, China
    • Boehringer Ingelheim Investigational Site 78
  • Hangzhou, China
    • Boehringer Ingelheim Investigational Site 28
  • Hangzhou, China
    • Boehringer Ingelheim Investigational Site 29
  • Hangzhou, China
    • Boehringer Ingelheim Investigational Site 30
  • Hangzhou, China
    • Boehringer Ingelheim Investigational Site 31
  • Hangzhou, China
    • Boehringer Ingelheim Investigational Site 32
  • Hefei, China
    • Boehringer Ingelheim Investigational Site 38
  • Jinan, China
    • Boehringer Ingelheim Investigational Site 39
  • Jinan, China
    • Boehringer Ingelheim Investigational Site 40
  • Luzhou, China
    • Boehringer Ingelheim Investigational Site 96
  • Nanchang, China
    • Boehringer Ingelheim Investigational Site 53
  • Nanjing, China
    • Boehringer Ingelheim Investigational Site 44
  • Nanjing, China
    • Boehringer Ingelheim Investigational Site 45
  • Nanjing, China
    • Boehringer Ingelheim Investigational Site 46
  • Nanjing, China
    • Boehringer Ingelheim Investigational Site 47
  • Nanjing, China
    • Boehringer Ingelheim Investigational Site 48
  • Nantong, China
    • Boehringer Ingelheim Investigational Site 49
  • Qingdao, China
    • Boehringer Ingelheim Investigational Site 43
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 17
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 18
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 19
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 20
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 21
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 22
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 23
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 24
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 25
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 26
  • Shanghai, China
    • Boehringer Ingelheim Investigational Site 27
  • Shantou, China
    • Boehringer Ingelheim Investigational Site 92
  • Shenyang, China
    • Boehringer Ingelheim Investigational Site 73
  • Shenyang, China
    • Boehringer Ingelheim Investigational Site 74
  • Shenyang, China
    • Boehringer Ingelheim Investigational Site 75
  • Shenyang, China
    • Boehringer Ingelheim Investigational Site 76
  • Shenzhen, China
    • Boehringer Ingelheim Investigational Site 93
  • Shijiazhuang, China
    • Boehringer Ingelheim Investigational Site 2
  • Shijiazhuang, China
    • Boehringer Ingelheim Investigational Site 3
  • Shiyan, China
    • Boehringer Ingelheim Investigational Site 6
  • Suzhou, China
    • Boehringer Ingelheim Investigational Site 51
  • Suzhou, China
    • Boehringer Ingelheim Investigational Site 52
  • Taiyuan, China
    • Boehringer Ingelheim Investigational Site 1
  • Tianjin, China
    • Boehringer Ingelheim Investigational Site 68
  • Tianjin, China
    • Boehringer Ingelheim Investigational Site 69
  • Tianjin, China
    • Boehringer Ingelheim Investigational Site 70
  • Weifang, China
    • Boehringer Ingelheim Investigational Site 41
  • Wenzhou, China
    • Boehringer Ingelheim Investigational Site 33
  • Wuhan, China
    • Boehringer Ingelheim Investigational Site 10
  • Wuhan, China
    • Boehringer Ingelheim Investigational Site 11
  • Wuhan, China
    • Boehringer Ingelheim Investigational Site 7
  • Wuhan, China
    • Boehringer Ingelheim Investigational Site 8
  • Wuhan, China
    • Boehringer Ingelheim Investigational Site 9
  • Wuxi, China
    • Boehringer Ingelheim Investigational Site 50
  • Xiamen, China
    • Boehringer Ingelheim Investigational Site 34
  • Xian, China
    • Boehringer Ingelheim Investigational Site 102
  • Xian, China
    • Boehringer Ingelheim Investigational Site 103
  • Yantai, China
    • Boehringer Ingelheim Investigational Site 42
  • Zhengzhou, China
    • Boehringer Ingelheim Investigational Site 4
  • Zhengzhou, China
    • Boehringer Ingelheim Investigational Site 5

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

3000

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pramipexole group; It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.	Drug: pramipexole; as prescibed by the investigator

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: May 25, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Estimate): May 16, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Dopamine Agonists; Dopamine Agents; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Pramipexole
• Other Study ID Numbers: 248.682