First Presentation of Parkinson Disease Patients to Neurologist

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 311 sites in 9 countries.

Completed

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

Trial summary

In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson Disease
How many people: 2,448 participants
Where: 311 sitesin 9 countries
Study dates: Feb 2006to Sep 2007
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: neurogologists

Who may be able to join

Parkinson Disease patients presenting to neurologist for first time

Who cannot join

Hypersensitivity to the active substance or to any of the excipients

Trial locations and contacts

311 sites in 9 countries.

Country

City, postcode or hospital

311 sites in 9 countries

Czechia104 sites

Boehringer Ingelheim Investigational Site
Blansko
Boehringer Ingelheim Investigational Site
Brandýs N. Orlicí
Boehringer Ingelheim Investigational Site 1
Brno
Boehringer Ingelheim Investigational Site 2
Brno
Boehringer Ingelheim Investigational Site
Bystřice N. Pernštejnem
Boehringer Ingelheim Investigational Site
Černožice
Boehringer Ingelheim Investigational Site 1
Česká Lípa
Boehringer Ingelheim Investigational Site 2
Česká Lípa
Boehringer Ingelheim Investigational Site 1
České Budějovice
Boehringer Ingelheim Investigational Site 2
České Budějovice
Boehringer Ingelheim Investigational Site 3
České Budějovice
Boehringer Ingelheim Investigational Site 4
České Budějovice
Boehringer Ingelheim Investigational Site
Český Krumlov
Boehringer Ingelheim Investigational Site 1
Cheb
Boehringer Ingelheim Investigational Site 2
Cheb
Boehringer Ingelheim Investigational Site 3
Cheb
Boehringer Ingelheim Investigational Site 1
Chomutov
Boehringer Ingelheim Investigational Site 2
Chomutov
Boehringer Ingelheim Investigational Site
Frýdek-Místek
Boehringer Ingelheim Investigational Site
Havíov
Boehringer Ingelheim Investigational Site
Hodonín
Boehringer Ingelheim Investigational Site
Holešov
Boehringer Ingelheim Investigational Site
Hradec Králové
Boehringer Ingelheim Investigational Site
Jablonec N. Nisou
Boehringer Ingelheim Investigational Site
Jičín
Boehringer Ingelheim Investigational Site
Jilemnice
Boehringer Ingelheim Investigational Site 1
Karlovy Vary
Boehringer Ingelheim Investigational Site 2
Karlovy Vary
Boehringer Ingelheim Investigational Site
Kladno
Boehringer Ingelheim Investigational Site
Kolín
Boehringer Ingelheim Investigational Site 1
Kroměříz
Boehringer Ingelheim Investigational Site 2
Kroměříz
Boehringer Ingelheim Investigational Site 1
Kyjov
Boehringer Ingelheim Investigational Site 2
Kyjov
Boehringer Ingelheim Investigational Site 1
Liberec
Boehringer Ingelheim Investigational Site 2
Liberec
Boehringer Ingelheim Investigational Site 3
Liberec
Boehringer Ingelheim Investigational Site
Lipník nad Bečvou
Boehringer Ingelheim Investigational Site 1
Litoměřice
Boehringer Ingelheim Investigational Site 2
Litoměřice
Boehringer Ingelheim Investigational Site 1
Litomyšl
Boehringer Ingelheim Investigational Site 2
Litomyšl
Boehringer Ingelheim Investigational Site
Litovel
Boehringer Ingelheim Investigational Site
Mladá Boleslav
Boehringer Ingelheim Investigational Site
Moravské Budějovice
Boehringer Ingelheim Investigational Site
Moravský Krumlov
Boehringer Ingelheim Investigational Site
Náchod
Boehringer Ingelheim Investigational Site 1
Olomouc
Boehringer Ingelheim Investigational Site 2
Olomouc
Boehringer Ingelheim Investigational Site 3
Olomouc
Boehringer Ingelheim Investigational Site 4
Olomouc
Boehringer Ingelheim Investigational Site 5
Olomouc
Boehringer Ingelheim Investigational Site 6
Olomouc
Boehringer Ingelheim Investigational Site 7
Olomouc
Boehringer Ingelheim Investigational Site
Opava
Boehringer Ingelheim Investigational Site
Ostrava - Poruba
Boehringer Ingelheim Investigational Site
Ostrava Pustkovec
Boehringer Ingelheim Investigational Site 1
Pilsen
Boehringer Ingelheim Investigational Site 2
Pilsen
Boehringer Ingelheim Investigational Site 3
Pilsen
Boehringer Ingelheim Investigational Site 4
Pilsen
Boehringer Ingelheim Investigational Site 5
Pilsen
Boehringer Ingelheim Investigational Site 6
Pilsen
Boehringer Ingelheim Investigational Site 7
Pilsen
Boehringer Ingelheim Investigational Site
Písek
Boehringer Ingelheim Investigational Site 10
Prague
Boehringer Ingelheim Investigational Site 11
Prague
Boehringer Ingelheim Investigational Site 13
Prague
Boehringer Ingelheim Investigational Site 14
Prague
Boehringer Ingelheim Investigational Site 15
Prague
Boehringer Ingelheim Investigational Site 16
Prague
Boehringer Ingelheim Investigational Site 17
Prague
Boehringer Ingelheim Investigational Site 18
Prague
Boehringer Ingelheim Investigational Site 19
Prague
Boehringer Ingelheim Investigational Site 1
Prague
Boehringer Ingelheim Investigational Site 20
Prague
Boehringer Ingelheim Investigational Site 21
Prague
Boehringer Ingelheim Investigational Site 2
Prague
Boehringer Ingelheim Investigational Site 3
Prague
Boehringer Ingelheim Investigational Site 4
Prague
Boehringer Ingelheim Investigational Site 5
Prague
Boehringer Ingelheim Investigational Site 6
Prague
Boehringer Ingelheim Investigational Site 7
Prague
Boehringer Ingelheim Investigational Site 8
Prague
Boehringer Ingelheim Investigational Site 9
Prague
Boehringer Ingelheim Investigational Site 12
Praha 4 - Kamýk
Boehringer Ingelheim Investigational Site
Přerov
Boehringer Ingelheim Investigational Site
Přeštice
Boehringer Ingelheim Investigational Site 1
Příbram
Boehringer Ingelheim Investigational Site 2
Příbram
Boehringer Ingelheim Investigational Site
Srubec, České Budějovice
Boehringer Ingelheim Investigational Site
Stenberk
Boehringer Ingelheim Investigational Site
Strakonice
Boehringer Ingelheim Investigational Site
Svitavy
Boehringer Ingelheim Investigational Site
Teplice
Boehringer Ingelheim Investigational Site
Třebíč
Boehringer Ingelheim Investigational Site
Třinec
Boehringer Ingelheim Investigational Site
Trutnov
Boehringer Ingelheim Investigational Site
Ústí N. Labem
Boehringer Ingelheim Investigational Site
Vojnův Městec
Boehringer Ingelheim Investigational Site 1
Žďár N. Sázavou
Boehringer Ingelheim Investigational Site 2
Žďár N. Sázavou
Boehringer Ingelheim Investigational Site
Zlín
Boehringer Ingelheim Investigational Site
Znojmo

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Romania75 sites

Boehringer Ingelheim Investigational Site
Alba Iulia
Boehringer Ingelheim Investigational Site
Arad
Boehringer Ingelheim Investigational Site
Bacau
Boehringer Ingelheim Investigational Site 1
Baia Mare
Boehringer Ingelheim Investigational Site 2
Baia Mare
Boehringer Ingelheim Investigational Site
Bistriţa
Boehringer Ingelheim Investigational Site
Brasov
Boehringer Ingelheim Investigational Site 10
Bucharest
Boehringer Ingelheim Investigational Site 11
Bucharest
Boehringer Ingelheim Investigational Site 12
Bucharest
Boehringer Ingelheim Investigational Site 13
Bucharest
Boehringer Ingelheim Investigational Site 14
Bucharest
Boehringer Ingelheim Investigational Site 15
Bucharest
Boehringer Ingelheim Investigational Site 16
Bucharest
Boehringer Ingelheim Investigational Site 17
Bucharest
Boehringer Ingelheim Investigational Site 18
Bucharest
Boehringer Ingelheim Investigational Site 19
Bucharest
Boehringer Ingelheim Investigational Site 1
Bucharest
Boehringer Ingelheim Investigational Site 20
Bucharest
Boehringer Ingelheim Investigational Site 21
Bucharest
Boehringer Ingelheim Investigational Site 2
Bucharest
Boehringer Ingelheim Investigational Site 3
Bucharest
Boehringer Ingelheim Investigational Site 4
Bucharest
Boehringer Ingelheim Investigational Site 5
Bucharest
Boehringer Ingelheim Investigational Site 6
Bucharest
Boehringer Ingelheim Investigational Site 7
Bucharest
Boehringer Ingelheim Investigational Site 8
Bucharest
Boehringer Ingelheim Investigational Site 9
Bucharest
Boehringer Ingelheim Investigational Site 1
Buzău
Boehringer Ingelheim Investigational Site 2
Buzău
Boehringer Ingelheim Investigational Site 3
Buzău
Boehringer Ingelheim Investigational Site
Câmpina
Boehringer Ingelheim Investigational Site
Campulung Muscel
Boehringer Ingelheim Investigational Site 1
Cluj-Napoca
Boehringer Ingelheim Investigational Site 2
Cluj-Napoca
Boehringer Ingelheim Investigational Site 3
Cluj-Napoca
Boehringer Ingelheim Investigational Site 1
Constanța
Boehringer Ingelheim Investigational Site 2
Constanța
Boehringer Ingelheim Investigational Site 3
Constanța
Boehringer Ingelheim Investigational Site 1
Craiova
Boehringer Ingelheim Investigational Site 2
Craiova
Boehringer Ingelheim Investigational Site 3
Craiova
Boehringer Ingelheim Investigational Site 1
Curtea de Argeş
Boehringer Ingelheim Investigational Site 2
Curtea de Argeş
Boehringer Ingelheim Investigational Site
Deva
Boehringer Ingelheim Investigational Site
Drobeta-Turnu Severin
Boehringer Ingelheim Investigational Site 1
Galati
Boehringer Ingelheim Investigational Site 2
Galati
Boehringer Ingelheim Investigational Site
Giurgiu
Boehringer Ingelheim Investigational Site 1
Iași
Boehringer Ingelheim Investigational Site 2
Iași
Boehringer Ingelheim Investigational Site 3
Iași
Boehringer Ingelheim Investigational Site 4
Iași
Boehringer Ingelheim Investigational Site 1
Oradea
Boehringer Ingelheim Investigational Site 2
Oradea
Boehringer Ingelheim Investigational Site
Petroşani
Boehringer Ingelheim Investigational Site
Piatra Neamţ
Boehringer Ingelheim Investigational Site 1
Piteşti
Boehringer Ingelheim Investigational Site 2
Piteşti
Boehringer Ingelheim Investigational Site 1
Ploieşti
Boehringer Ingelheim Investigational Site 2
Ploieşti
Boehringer Ingelheim Investigational Site 3
Ploieşti
Boehringer Ingelheim Investigational Site
Rm Valcea
Boehringer Ingelheim Investigational Site 1
Satu Mare
Boehringer Ingelheim Investigational Site 2
Satu Mare
Boehringer Ingelheim Investigational Site
Sibiu
Boehringer Ingelheim Investigational Site
Slatina
Boehringer Ingelheim Investigational Site
Slobozia
Boehringer Ingelheim Investigational Site
Suceava
Boehringer Ingelheim Investigational Site
Tg Mures
Boehringer Ingelheim Investigational Site 1
Timișoara
Boehringer Ingelheim Investigational Site 2
Timișoara
Boehringer Ingelheim Investigational Site 3
Timișoara
Boehringer Ingelheim Investigational Site 4
Timișoara
Boehringer Ingelheim Investigational Site 5
Timișoara

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Slovakia45 sites

Boehringer Ingelheim Investigational Site
Bánovce N. Bebravou
Boehringer Ingelheim Investigational Site 1
Banská Bystrica
Boehringer Ingelheim Investigational Site 2
Banská Bystrica
Boehringer Ingelheim Investigational Site 3
Banská Bystrica
Boehringer Ingelheim Investigational Site 1
Bratislava
Boehringer Ingelheim Investigational Site 2
Bratislava
Boehringer Ingelheim Investigational Site 3
Bratislava
Boehringer Ingelheim Investigational Site 4
Bratislava
Boehringer Ingelheim Investigational Site 5
Bratislava
Boehringer Ingelheim Investigational Site
Dolný Kubín
Boehringer Ingelheim Investigational Site
Galanta
Boehringer Ingelheim Investigational Site
Komárno
Boehringer Ingelheim Investigational Site 1
Košice
Boehringer Ingelheim Investigational Site 2
Košice
Boehringer Ingelheim Investigational Site 3
Košice
Boehringer Ingelheim Investigational Site 4
Košice
Boehringer Ingelheim Investigational Site 5
Kosice- Saca
Boehringer Ingelheim Investigational Site
Levice
Boehringer Ingelheim Investigational Site
Liptovský Mikulás
Boehringer Ingelheim Investigational Site
Martin
Boehringer Ingelheim Investigational Site
Myjava
Boehringer Ingelheim Investigational Site 1
Nitra
Boehringer Ingelheim Investigational Site 2
Nitra
Boehringer Ingelheim Investigational Site
Nováky
Boehringer Ingelheim Investigational Site
Povazská Bystrica
Boehringer Ingelheim Investigational Site 1
Prešov
Boehringer Ingelheim Investigational Site 2
Prešov
Boehringer Ingelheim Investigational Site
Prievidza
Boehringer Ingelheim Investigational Site
Rimavská Sobota
Boehringer Ingelheim Investigational Site
Roz?ava
Boehringer Ingelheim Investigational Site
Ružomberok
Boehringer Ingelheim Investigational Site
Skalica
Boehringer Ingelheim Investigational Site
Sliač
Boehringer Ingelheim Investigational Site
Snina
Boehringer Ingelheim Investigational Site 2
Stará ?ubov?a
Boehringer Ingelheim Investigational Site 1
Stará Ľubovňa
Boehringer Ingelheim Investigational Site
Šurany
Boehringer Ingelheim Investigational Site
Topoľčany
Boehringer Ingelheim Investigational Site 1
Trebišov
Boehringer Ingelheim Investigational Site 2
Trebišov
Boehringer Ingelheim Investigational Site
Trnava
Boehringer Ingelheim Investigational Site
Trstená
Boehringer Ingelheim Investigational Site
Vranov nad Topľou
Boehringer Ingelheim Investigational Site 1
Žilina
Boehringer Ingelheim Investigational Site 2
Žilina

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Hungary40 sites

Boehringer Ingelheim Investigational Site
Balassagyarmat
Boehringer Ingelheim Investigational Site
Berettyóújfalu
Boehringer Ingelheim Investigational Site 10
Budapest
Boehringer Ingelheim Investigational Site 11
Budapest
Boehringer Ingelheim Investigational Site 12
Budapest
Boehringer Ingelheim Investigational Site 13
Budapest
Boehringer Ingelheim Investigational Site 14
Budapest
Boehringer Ingelheim Investigational Site 15
Budapest
Boehringer Ingelheim Investigational Site 1
Budapest
Boehringer Ingelheim Investigational Site 2
Budapest
Boehringer Ingelheim Investigational Site 3
Budapest
Boehringer Ingelheim Investigational Site 4
Budapest
Boehringer Ingelheim Investigational Site 5
Budapest
Boehringer Ingelheim Investigational Site 6
Budapest
Boehringer Ingelheim Investigational Site 7
Budapest
Boehringer Ingelheim Investigational Site 8
Budapest
Boehringer Ingelheim Investigational Site 9
Budapest
Boehringer Ingelheim Investigational Site 1
Debrecen
Boehringer Ingelheim Investigational Site 2
Debrecen
Boehringer Ingelheim Investigational Site
Dunaújváros
Boehringer Ingelheim Investigational Site
Eger
Boehringer Ingelheim Investigational Site
Esztergom
Boehringer Ingelheim Investigational Site
Gyõr
Boehringer Ingelheim Investigational Site
Hatvan
Boehringer Ingelheim Investigational Site
Kaposvár
Boehringer Ingelheim Investigational Site 1
Kecskemét
Boehringer Ingelheim Investigational Site 2
Kecskemét
Boehringer Ingelheim Investigational Site
Kistarcsa
Boehringer Ingelheim Investigational Site
Kisvárda
Boehringer Ingelheim Investigational Site
Miskolc
Boehringer Ingelheim Investigational Site
Nyíregyháza
Boehringer Ingelheim Investigational Site 1
Pécs
Boehringer Ingelheim Investigational Site 2
Pécs
Boehringer Ingelheim Investigational Site
Ráckeve
Boehringer Ingelheim Investigational Site
Salgótarján
Boehringer Ingelheim Investigational Site
Sopron
Boehringer Ingelheim Investigational Site
Szekszárd
Boehringer Ingelheim Investigational Site
Szentendre
Boehringer Ingelheim Investigational Site
Vác
Boehringer Ingelheim Investigational Site
Veszprém

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Serbia18 sites

Boehringer Ingelheim Investigational Site
Arandjelovac
Boehringer Ingelheim Investigational Site 1
Belgrade
Boehringer Ingelheim Investigational Site 2
Belgrade
Boehringer Ingelheim Investigational Site 3
Belgrade
Boehringer Ingelheim Investigational Site 4
Belgrade
Boehringer Ingelheim Investigational Site
Kikinda
Boehringer Ingelheim Investigational Site
Knjazevac
Boehringer Ingelheim Investigational Site
Kragujevac
Boehringer Ingelheim Investigational Site
Kruševac
Boehringer Ingelheim Investigational Site
Loznica
Boehringer Ingelheim Investigational Site
Negotin
Boehringer Ingelheim Investigational Site
Niš
Boehringer Ingelheim Investigational Site
Novi Sad
Boehringer Ingelheim Investigational Site
Sombor
Boehringer Ingelheim Investigational Site
Sremska Mitrovica
Boehringer Ingelheim Investigational Site
Subotica
Boehringer Ingelheim Investigational Site
Vranje
Boehringer Ingelheim Investigational Site
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Croatia11 sites

Boehringer Ingelheim Investigational Site
Bjelovar
Boehringer Ingelheim Investigational Site
Dubrovnik
Boehringer Ingelheim Investigational Site
Gospić
Boehringer Ingelheim Investigational Site
Karlovac
Boehringer Ingelheim Investigational Site
Požega
Boehringer Ingelheim Investigational Site
Pula
Boehringer Ingelheim Investigational Site
Rijeka
Boehringer Ingelheim Investigational Site
Šibenik
Boehringer Ingelheim Investigational Site
Sisak
Boehringer Ingelheim Investigational Site
Split
Boehringer Ingelheim Investigational Site
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Slovenia10 sites

Boehringer ingelheim Investigational Site 1
Ljubljana
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Ljubljana
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Ljubljana
Boehringer ingelheim Investigational Site 4
Ljubljana
Boehringer ingelheim Investigational Site 5
Ljubljana
Boehringer ingelheim Investigational Site 1
Maribor
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Maribor
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Maribor
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Maribor
Boehringer ingelheim Investigational Site 1
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Estonia4 sites

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Pärnu
Boehringer Ingelheim Investigational Site
Tallinn
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Russia4 sites

Boehringer Ingelheim Investigational Site 1
Moscow
Boehringer Ingelheim Investigational Site 2
Moscow
Boehringer Ingelheim Investigational Site 1
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About this study

Official title: CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) First Presentation of Mirapexin in Parkinson Patients

In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time

Conditions: Parkinson Disease
Medical subject headings: Parkinson Disease

What is being measured

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

Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated
Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
De-novo patients were identified by:
those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)
Measured: 4 - 8 weeks

Secondary outcomes (3)

Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I
Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)
Measured: Baseline and 4 to 8 weeks
Change From Baseline in UPDRS Part III
Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).
Measured: Baseline and 4 - 8 weeks
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients
Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
Measured: 4 - 8 weeks

Timeline

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

Feb 2006Sep 2007

First posted4 Dec 2008 (estimated)
Study startFeb 2006
Primary completionSep 2007

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: Cohort
Time perspective: Prospective
Enrolment: 2,448 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00802178
Sponsor's protocol ID: 248.613
Status last verified: Mar 2014
First submitted: 3 Dec 2008
Last updated: 11 Apr 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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) First Presentation of Mirapexin in Parkinson Patients
ClinicalTrials.gov ID: NCT00802178
Acronym / sponsor ID: 248.613
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 2,448 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Sep 2007 (actual)
First posted: 4 Dec 2008 (estimated)
Results: Posted 20 Nov 2009

Clinical summary

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

In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: neurogologists

Key inclusion criteria (1 listed)

Parkinson Disease patients presenting to neurologist for first time

Key exclusion criteria (1 listed)

Hypersensitivity to the active substance or to any of the excipients

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

Primary outcome

Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated
Time frame: 4 - 8 weeks
Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. De-novo patients were identified by: those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)

3 secondary outcomes

Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I
Time frame: Baseline and 4 to 8 weeks
Change From Baseline in UPDRS Part III
Time frame: Baseline and 4 - 8 weeks
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients
Time frame: 4 - 8 weeks

Results and safety

Results posted to the registry on 20 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mirapexin® (Pramipexole)	2,448	2,335

Primary outcome: Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated

Time frame: 4 - 8 weeks. Number. Unit: Participants

Measure	Mirapexin® (Pramipexole) n = 833
Very good	403
Good	323
Moderate	73
Poor	15
Global Clinical Assessment (GCA) missing	19

Population analysed: Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: During 4 - 8 weeks of therapy. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirapexin® (Pramipexole)	0 of 2,448 (0%)	0 of 2,448 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

311 sites in 9 countries: 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 311 sites in 9 countries.

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 1 inclusion and 1 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 311 sites in Czechia, Romania, Slovakia, Hungary, Serbia and 4 more countries. 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 20 Nov 2009). 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?

Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated (time frame: 4 - 8 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 NCT00802178.

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 11 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.