Parkinson DiseaseNCT01361009

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

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 103 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Parkinson Disease
What is being tested?: pramipexole
How many people: 2,017 participants
Where: 103 sitesChina
Study dates: May 2011to Feb 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: 3000

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

103 sites in 1 country.

City, postcode or hospital

103 sites in 1 country

China103 sites

Boehringer Ingelheim Investigational Site 54
Beijing
Boehringer Ingelheim Investigational Site 55
Beijing
Boehringer Ingelheim Investigational Site 56
Beijing
Boehringer Ingelheim Investigational Site 57
Beijing
Boehringer Ingelheim Investigational Site 58
Beijing
Boehringer Ingelheim Investigational Site 59
Beijing
Boehringer Ingelheim Investigational Site 60
Beijing
Boehringer Ingelheim Investigational Site 61
Beijing
Boehringer Ingelheim Investigational Site 62
Beijing
Boehringer Ingelheim Investigational Site 63
Beijing
Boehringer Ingelheim Investigational Site 64
Beijing
Boehringer Ingelheim Investigational Site 65
Beijing
Boehringer Ingelheim Investigational Site 66
Changchun
Boehringer Ingelheim Investigational Site 67
Changchun
Boehringer Ingelheim Investigational Site 12
Changsh
Boehringer Ingelheim Investigational Site 13
Changsh
Boehringer Ingelheim Investigational Site 14
Changsh
Boehringer Ingelheim Investigational Site 15
Changsh
Boehringer Ingelheim Investigational Site 16
Changsh
Boehringer Ingelheim Investigational Site 94
Chendu
Boehringer Ingelheim Investigational Site 95
Chendu
Boehringer Ingelheim Investigational Site 100
Chongqing
Boehringer Ingelheim Investigational Site 101
Chongqing
Boehringer Ingelheim Investigational Site 97
Chongqing
Boehringer Ingelheim Investigational Site 98
Chongqing
Boehringer Ingelheim Investigational Site 99
Chongqing
Boehringer Ingelheim Investigational Site 71
Dalian
Boehringer Ingelheim Investigational Site 72
Dalian
Boehringer Ingelheim Investigational Site 79
Daqing
Boehringer Ingelheim Investigational Site 35
Fuzhou
Boehringer Ingelheim Investigational Site 36
Fuzhou
Boehringer Ingelheim Investigational Site 37
Fuzhou
Boehringer Ingelheim Investigational Site 80
Guangzhou
Boehringer Ingelheim Investigational Site 81
Guangzhou
Boehringer Ingelheim Investigational Site 82
Guangzhou
Boehringer Ingelheim Investigational Site 83
Guangzhou
Boehringer Ingelheim Investigational Site 84
Guangzhou
Boehringer Ingelheim Investigational Site 85
Guangzhou
Boehringer Ingelheim Investigational Site 86
Guangzhou
Boehringer Ingelheim Investigational Site 87
Guangzhou
Boehringer Ingelheim Investigational Site 88
Guangzhou
Boehringer Ingelheim Investigational Site 89
Guangzhou
Boehringer Ingelheim Investigational Site 90
Guangzhou
Boehringer Ingelheim Investigational Site 91
Guangzhou
Boehringer Ingelheim Investigational Site 77
Haerbin
Boehringer Ingelheim Investigational Site 78
Haerbin
Boehringer Ingelheim Investigational Site 28
Hangzhou
Boehringer Ingelheim Investigational Site 29
Hangzhou
Boehringer Ingelheim Investigational Site 30
Hangzhou
Boehringer Ingelheim Investigational Site 31
Hangzhou
Boehringer Ingelheim Investigational Site 32
Hangzhou
Boehringer Ingelheim Investigational Site 38
Hefei
Boehringer Ingelheim Investigational Site 39
Jinan
Boehringer Ingelheim Investigational Site 40
Jinan
Boehringer Ingelheim Investigational Site 96
Luzhou
Boehringer Ingelheim Investigational Site 53
Nanchang
Boehringer Ingelheim Investigational Site 44
Nanjing
Boehringer Ingelheim Investigational Site 45
Nanjing
Boehringer Ingelheim Investigational Site 46
Nanjing
Boehringer Ingelheim Investigational Site 47
Nanjing
Boehringer Ingelheim Investigational Site 48
Nanjing
Boehringer Ingelheim Investigational Site 49
Nantong
Boehringer Ingelheim Investigational Site 43
Qingdao
Boehringer Ingelheim Investigational Site 17
Shanghai
Boehringer Ingelheim Investigational Site 18
Shanghai
Boehringer Ingelheim Investigational Site 19
Shanghai
Boehringer Ingelheim Investigational Site 20
Shanghai
Boehringer Ingelheim Investigational Site 21
Shanghai
Boehringer Ingelheim Investigational Site 22
Shanghai
Boehringer Ingelheim Investigational Site 23
Shanghai
Boehringer Ingelheim Investigational Site 24
Shanghai
Boehringer Ingelheim Investigational Site 25
Shanghai
Boehringer Ingelheim Investigational Site 26
Shanghai
Boehringer Ingelheim Investigational Site 27
Shanghai
Boehringer Ingelheim Investigational Site 92
Shantou
Boehringer Ingelheim Investigational Site 73
Shenyang
Boehringer Ingelheim Investigational Site 74
Shenyang
Boehringer Ingelheim Investigational Site 75
Shenyang
Boehringer Ingelheim Investigational Site 76
Shenyang
Boehringer Ingelheim Investigational Site 93
Shenzhen
Boehringer Ingelheim Investigational Site 2
Shijiazhuang
Boehringer Ingelheim Investigational Site 3
Shijiazhuang
Boehringer Ingelheim Investigational Site 6
Shiyan
Boehringer Ingelheim Investigational Site 51
Suzhou
Boehringer Ingelheim Investigational Site 52
Suzhou
Boehringer Ingelheim Investigational Site 1
Taiyuan
Boehringer Ingelheim Investigational Site 68
Tianjin
Boehringer Ingelheim Investigational Site 69
Tianjin
Boehringer Ingelheim Investigational Site 70
Tianjin
Boehringer Ingelheim Investigational Site 41
Weifang
Boehringer Ingelheim Investigational Site 33
Wenzhou
Boehringer Ingelheim Investigational Site 10
Wuhan
Boehringer Ingelheim Investigational Site 11
Wuhan
Boehringer Ingelheim Investigational Site 7
Wuhan
Boehringer Ingelheim Investigational Site 8
Wuhan
Boehringer Ingelheim Investigational Site 9
Wuhan
Boehringer Ingelheim Investigational Site 50
Wuxi
Boehringer Ingelheim Investigational Site 102
Xi'an
Boehringer Ingelheim Investigational Site 103
Xi'an
Boehringer Ingelheim Investigational Site 34
Xiamen
Boehringer Ingelheim Investigational Site 42
Yantai
Boehringer Ingelheim Investigational Site 4
Zhengzhou
Boehringer Ingelheim Investigational Site 5
Zhengzhou

Other trials in China

About this study

Official title: 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.

Read the detailed description

Purpose:

Conditions: Parkinson Disease
Being tested: pramipexole
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pramipexoleDrug
as prescibed by the investigator

Study groups in NCT01361009
Study group	Role	What they receive
pramipexole group		It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world. Receives: Drug: pramipexole

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Secondary outcomes (3)

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).
Measured: 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.
Measured: 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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Feb 2012

First posted26 May 2011 (estimated)
Study startMay 2011
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 2,017 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01361009
Sponsor's protocol ID: 248.682
Status last verified: Jun 2013
First submitted: 23 May 2011
Last updated: 16 May 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
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Cervical Cancer
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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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Adaptive DBS to Offset STN Dysregulation During Exercise in PD
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All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance
ClinicalTrials.gov ID: NCT01361009
Acronym / sponsor ID: 248.682
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 2,017 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 26 May 2011 (estimated)
Results: Posted 30 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Purpose:

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
pramipexole group	–	Drug: pramipexoleIt's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 3000

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pramipexoleas prescibed by the investigator	Drug	pramipexole group

Primary outcome

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

3 secondary outcomes

Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)
Time frame: Baseline (Visit 1) and 12 weeks (Visit 3)
The Dosage Related Information of Pramipexole at Baseline
Time frame: baseline
The Dosage Related Information of Pramipexole at the End of Study
Time frame: 12 weeks

Results and safety

Results posted to the registry on 30 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pramipexole Goup	2,017	1,901

Primary outcome: Incidence of AE/SAE

Time frame: 12 weeks. Number. Unit: Percentage of participants

Measure	Pramipexole Goup n = 2017
Value	5.16

Population analysed: There were 2017 patients in the safety analysis set (SAS). SAS includes the patients who took drug at least once and had safety data. In this study, 2017 patients were recruited, who have been using pramipexole before the enrollment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pramipexole Goup	0 of 2,017 (0%)	0 of 2,017 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Parkinson Disease

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

103 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 103 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of AE/SAE (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01361009.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.