Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 273 sites in Japan.

Completed

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

Trial summary

The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan. Read more about this study

Who is it for?: Any age
Conditions the study is for: Parkinson Disease
How many people: 1,645 participants
Where: 273 sitesJapan
Study dates: Feb 2004to Mar 2009
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Parkinson's disease patients in daily clinical settings

Who may be able to join

Patients with Parkinson's disease

Who cannot join

Patients should have been treated according to the Japanese insert slip

Trial locations and contacts

273 sites in 1 country.

City, postcode or hospital

273 sites in 1 country

Japan273 sites

Boehringer Ingelheim Investigational Site
Agano
Boehringer Ingelheim Investigational Site
Aizu-Wakamatsu
Boehringer Ingelheim Investigational Site
Akashi
Boehringer Ingelheim Investigational Site
Akita
Boehringer Ingelheim Investigational Site
Asahikawa
Boehringer Ingelheim Investigational Site
Asakura
Boehringer Ingelheim Investigational Site
Azumino
Boehringer Ingelheim Investigational Site
Bandō
Boehringer Ingelheim Investigational Site
Beppu
Boehringer Ingelheim Investigational Site
Bihoro
Boehringer Ingelheim Investigational Site
Chiba
Boehringer Ingelheim Investigational Site
Chikusei
Boehringer Ingelheim Investigational Site
Chūō
Boehringer Ingelheim Investigational Site
Date
Boehringer Ingelheim Investigational Site
Ebetsu
Boehringer Ingelheim Investigational Site
Ebina
Boehringer Ingelheim Investigational Site
Fuchū
Boehringer Ingelheim Investigational Site
Fuji
Boehringer Ingelheim Investigational Site
Fujieda
Boehringer Ingelheim Investigational Site
Fujinomiya
Boehringer Ingelheim Investigational Site
Fujioka
Boehringer Ingelheim Investigational Site
Fujisawa
Boehringer Ingelheim Investigational Site
Fujiyoshida
Boehringer Ingelheim Investigational Site
Fukaya
Boehringer Ingelheim Investigational Site
Fukui
Boehringer Ingelheim Investigational Site
Fukuoka
Boehringer Ingelheim Investigational Site
Fukushima
Boehringer Ingelheim Investigational Site
Fukuyama
Boehringer Ingelheim Investigational Site
Gifu
Boehringer Ingelheim Investigational Site
Ginowan
Boehringer Ingelheim Investigational Site
Hachinohe
Boehringer Ingelheim Investigational Site
Hadano
Boehringer Ingelheim Investigational Site
Hagahama
Boehringer Ingelheim Investigational Site
Hakodate
Boehringer Ingelheim Investigational Site
Hamada
Boehringer Ingelheim Investigational Site
Hamamatsu
Boehringer Ingelheim Investigational Site
Hayashima
Boehringer Ingelheim Investigational Site
Higashimurayama
Boehringer Ingelheim Investigational Site
Higashiosaka
Boehringer Ingelheim Investigational Site
Higashiyamato
Boehringer Ingelheim Investigational Site
Himeji
Boehringer Ingelheim Investigational Site
Hiratsuka
Boehringer Ingelheim Investigational Site
Hirokawa
Boehringer Ingelheim Investigational Site
Hirosaki
Boehringer Ingelheim Investigational Site
Hiroshima
Boehringer Ingelheim Investigational Site
Hita
Boehringer Ingelheim Investigational Site
Hōfu
Boehringer Ingelheim Investigational Site
Ibaraki
Boehringer Ingelheim Investigational Site
Ichikikushikino
Boehringer Ingelheim Investigational Site
Ichinomiya
Boehringer Ingelheim Investigational Site
Ichinoseki
Boehringer Ingelheim Investigational Site
Iijima
Boehringer Ingelheim Investigational Site
Iizuka
Boehringer Ingelheim Investigational Site
Ikeda
Boehringer Ingelheim Investigational Site
Ikoma
Boehringer Ingelheim Investigational Site
Ina
Boehringer Ingelheim Investigational Site
Inazawa
Boehringer Ingelheim Investigational Site
Inba
Boehringer Ingelheim Investigational Site
Inuyama
Boehringer Ingelheim Investigational Site
Isesaki
Boehringer Ingelheim Investigational Site
Itoigawa
Boehringer Ingelheim Investigational Site
Iwaki
Boehringer Ingelheim Investigational Site
Iwata
Boehringer Ingelheim Investigational Site
Jōetsu
Boehringer Ingelheim Investigational Site
Kagoshima
Boehringer Ingelheim Investigational Site
Kahoku
Boehringer Ingelheim Investigational Site
Kajiki
Boehringer Ingelheim Investigational Site
Kakegawa
Boehringer Ingelheim Investigational Site
Kakogawa
Boehringer Ingelheim Investigational Site
Kamisu
Boehringer Ingelheim Investigational Site
Kamogawa
Boehringer Ingelheim Investigational Site
Kanazawa
Boehringer Ingelheim Investigational Site
Kanegusuku
Boehringer Ingelheim Investigational Site
Kannonji
Boehringer Ingelheim Investigational Site
Karatsu
Boehringer Ingelheim Investigational Site
Kashima
Boehringer Ingelheim Investigational Site
Kashiwa
Boehringer Ingelheim Investigational Site
Kashiwazaki
Boehringer Ingelheim Investigational Site
Kasukabe
Boehringer Ingelheim Investigational Site
Katō
Boehringer Ingelheim Investigational Site
Kawagoe
Boehringer Ingelheim Investigational Site
Kawasaki
Boehringer Ingelheim Investigational Site
Kawatana
Boehringer Ingelheim Investigational Site
Kikugawa
Boehringer Ingelheim Investigational Site
Kirishima
Boehringer Ingelheim Investigational Site
Kitakyushu
Boehringer Ingelheim Investigational Site
Kiyose
Boehringer Ingelheim Investigational Site
Kiyotake
Boehringer Ingelheim Investigational Site
Kizugawa
Boehringer Ingelheim Investigational Site
Kobayashi
Boehringer Ingelheim Investigational Site
Kobe
Boehringer Ingelheim Investigational Site
Kochi
Boehringer Ingelheim Investigational Site
Kodaira
Boehringer Ingelheim Investigational Site
Kofu
Boehringer Ingelheim Investigational Site
Koga
Boehringer Ingelheim Investigational Site
Koga
Boehringer Ingelheim Investigational Site
Kokubunji
Boehringer Ingelheim Investigational Site
Komae
Boehringer Ingelheim Investigational Site
Komatsu
Boehringer Ingelheim Investigational Site
Komoro
Boehringer Ingelheim Investigational Site
Kōriyama
Boehringer Ingelheim Investigational Site
Kōshi
Boehringer Ingelheim Investigational Site
Koshikawa
Boehringer Ingelheim Investigational Site
Kōtari
Boehringer Ingelheim Investigational Site
Kumamoto
Boehringer Ingelheim Investigational Site
Kurashiki
Boehringer Ingelheim Investigational Site
Kurayoshi
Boehringer Ingelheim Investigational Site
Kure
Boehringer Ingelheim Investigational Site
Kurume
Boehringer Ingelheim Investigational Site
Kushiro
Boehringer Ingelheim Investigational Site
Kutchan
Boehringer Ingelheim Investigational Site
Kuwana
Boehringer Ingelheim Investigational Site
Kyoto
Boehringer Ingelheim Investigational Site
Maebaru
Boehringer Ingelheim Investigational Site
Maebashi
Boehringer Ingelheim Investigational Site
Maibara
Boehringer Ingelheim Investigational Site
Maizuru
Boehringer Ingelheim Investigational Site
Marugame
Boehringer Ingelheim Investigational Site
Matsuda
Boehringer Ingelheim Investigational Site
Matsudo
Boehringer Ingelheim Investigational Site
Matsue
Boehringer Ingelheim Investigational Site
Matsumoto
Boehringer Ingelheim Investigational Site
Matsuyama
Boehringer Ingelheim Investigational Site
Mibu
Boehringer Ingelheim Investigational Site
Mihara
Boehringer Ingelheim Investigational Site
Miki
Boehringer Ingelheim Investigational Site
Minakami
Boehringer Ingelheim Investigational Site
Minamata
Boehringer Ingelheim Investigational Site
Minobu
Boehringer Ingelheim Investigational Site
Misashino
Boehringer Ingelheim Investigational Site
Mito
Boehringer Ingelheim Investigational Site
Miyaki
Boehringer Ingelheim Investigational Site
Miyakonojō
Boehringer Ingelheim Investigational Site
Miyazaki
Boehringer Ingelheim Investigational Site
Mooka
Boehringer Ingelheim Investigational Site
Moriguchi
Boehringer Ingelheim Investigational Site
Morioka
Boehringer Ingelheim Investigational Site
Moriya
Boehringer Ingelheim Investigational Site
Moriyama
Boehringer Ingelheim Investigational Site
Motona
Boehringer Ingelheim Investigational Site
Mukai-awagasaki
Boehringer Ingelheim Investigational Site
Muroran
Boehringer Ingelheim Investigational Site
Nagakute
Boehringer Ingelheim Investigational Site
Nagaoka
Boehringer Ingelheim Investigational Site
Nagasaki
Boehringer Ingelheim Investigational Site
Nagoya
Boehringer Ingelheim Investigational Site
Nangōku
Boehringer Ingelheim Investigational Site
Nara
Boehringer Ingelheim Investigational Site
Narita
Boehringer Ingelheim Investigational Site
Narutō
Boehringer Ingelheim Investigational Site
Nichinan
Boehringer Ingelheim Investigational Site
Niigata
Boehringer Ingelheim Investigational Site
Niihama
Boehringer Ingelheim Investigational Site
Nikkō
Boehringer Ingelheim Investigational Site
Nishigō
Boehringer Ingelheim Investigational Site
Nishihara
Boehringer Ingelheim Investigational Site
Nishinomiya
Boehringer Ingelheim Investigational Site
Nishio
Boehringer Ingelheim Investigational Site
Nishitōkyō
Boehringer Ingelheim Investigational Site
Nobeoka
Boehringer Ingelheim Investigational Site
Noboribetsu
Boehringer Ingelheim Investigational Site
Numazu
Boehringer Ingelheim Investigational Site
Obama
Boehringer Ingelheim Investigational Site
Obihiro
Boehringer Ingelheim Investigational Site
Ōdate
Boehringer Ingelheim Investigational Site
Odawara
Boehringer Ingelheim Investigational Site
Ōfunato
Boehringer Ingelheim Investigational Site
Ōgaki
Boehringer Ingelheim Investigational Site
Ohzu
Boehringer Ingelheim Investigational Site
Ōiso
Boehringer Ingelheim Investigational Site
Ōita
Boehringer Ingelheim Investigational Site
Ojiya
Boehringer Ingelheim Investigational Site
Ōkawa
Boehringer Ingelheim Investigational Site
Okayama
Boehringer Ingelheim Investigational Site
Omaezaki
Boehringer Ingelheim Investigational Site
Ōmura
Boehringer Ingelheim Investigational Site
Omuta
Boehringer Ingelheim Investigational Site
Ōnojō
Boehringer Ingelheim Investigational Site
Onomichi
Boehringer Ingelheim Investigational Site
Osaka
Boehringer Ingelheim Investigational Site
Ōtsu
Boehringer Ingelheim Investigational Site
Ōzu
Boehringer Ingelheim Investigational Site
Sado
Boehringer Ingelheim Investigational Site
Saga
Boehringer Ingelheim Investigational Site
Sagamihara
Boehringer Ingelheim Investigational Site
Saitama
Boehringer Ingelheim Investigational Site
Sakai
Boehringer Ingelheim Investigational Site
Sakaidechō
Boehringer Ingelheim Investigational Site
Sakata
Boehringer Ingelheim Investigational Site
Saku
Boehringer Ingelheim Investigational Site
Sanjō
Boehringer Ingelheim Investigational Site
Sano
Boehringer Ingelheim Investigational Site
Sanyōonoda
Boehringer Ingelheim Investigational Site
Sapporo
Boehringer Ingelheim Investigational Site
Sasebo
Boehringer Ingelheim Investigational Site
Seijō
Boehringer Ingelheim Investigational Site
Sendai
Boehringer Ingelheim Investigational Site
Shimabara
Boehringer Ingelheim Investigational Site
Shimonoseki
Boehringer Ingelheim Investigational Site
Shimotsuke
Boehringer Ingelheim Investigational Site
Shingū
Boehringer Ingelheim Investigational Site
Shinshiro
Boehringer Ingelheim Investigational Site
Shizuoka
Boehringer Ingelheim Investigational Site
Shūnan
Boehringer Ingelheim Investigational Site
Soo
Boehringer Ingelheim Investigational Site
Suita
Boehringer Ingelheim Investigational Site
Tajimi
Boehringer Ingelheim Investigational Site
Takamatsu
Boehringer Ingelheim Investigational Site
Takanabe
Boehringer Ingelheim Investigational Site
Takaoka
Boehringer Ingelheim Investigational Site
Takasago
Boehringer Ingelheim Investigational Site
Takasaki
Boehringer Ingelheim Investigational Site
Takatsuki
Boehringer Ingelheim Investigational Site
Takehara
Boehringer Ingelheim Investigational Site
Takinomiya
Boehringer Ingelheim Investigational Site
Toda
Boehringer Ingelheim Investigational Site
Togitsu
Boehringer Ingelheim Investigational Site
Tokoname
Boehringer Ingelheim Investigational Site
Tokushima
Boehringer Ingelheim Investigational Site
Tokyo Adachi-ku
Boehringer Ingelheim Investigational Site
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site
Tokyo Chiyoda-ku
Boehringer Ingelheim Investigational Site
Tokyo Edogawa-ku
Boehringer Ingelheim Investigational Site
Tokyo Itabashi-ku
Boehringer Ingelheim Investigational Site
Tokyo Katsushika-ku
Boehringer Ingelheim Investigational Site
Tokyo Kita-ku
Boehringer Ingelheim Investigational Site
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site
Tokyo Minayo-ku
Boehringer Ingelheim Investigational Site
Tokyo Nakano-ku
Boehringer Ingelheim Investigational Site
Tokyo Nerima-ku
Boehringer Ingelheim Investigational Site
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site
Tokyo Setagaya-ku
Boehringer Ingelheim Investigational Site
Tokyo Shinagawa-ku
Boehringer Ingelheim Investigational Site
Tokyo Shinjuku-ku
Boehringer Ingelheim Investigational Site
Tokyo Suginami-ku
Boehringer Ingelheim Investigational Site
Tokyo Toshima-ku
Boehringer Ingelheim Investigational Site
Tomakomai
Boehringer Ingelheim Investigational Site
Tomiai
Boehringer Ingelheim Investigational Site
Tondabayashi
Boehringer Ingelheim Investigational Site
Tōon
Boehringer Ingelheim Investigational Site
Toride
Boehringer Ingelheim Investigational Site
Toyama
Boehringer Ingelheim Investigational Site
Toyoake
Boehringer Ingelheim Investigational Site
Toyokawa
Boehringer Ingelheim Investigational Site
Toyonaka
Boehringer Ingelheim Investigational Site
Toyooka
Boehringer Ingelheim Investigational Site
Tsu
Boehringer Ingelheim Investigational Site
Tsubata
Boehringer Ingelheim Investigational Site
Tsuchiura
Boehringer Ingelheim Investigational Site
Tsukuba
Boehringer Ingelheim Investigational Site
Tsuruoka
Boehringer Ingelheim Investigational Site
Ueda
Boehringer Ingelheim Investigational Site
Uji
Boehringer Ingelheim Investigational Site
Ujo
Boehringer Ingelheim Investigational Site
Urayasu
Boehringer Ingelheim Investigational Site
Uruma
Boehringer Ingelheim Investigational Site
Utsunomiya
Boehringer Ingelheim Investigational Site
Wajiki
Boehringer Ingelheim Investigational Site
Wakayama
Boehringer Ingelheim Investigational Site
Yamagata
Boehringer Ingelheim Investigational Site
Yamaguchi
Boehringer Ingelheim Investigational Site
Yamamoto
Boehringer Ingelheim Investigational Site
Yanai
Boehringer Ingelheim Investigational Site
Yao
Boehringer Ingelheim Investigational Site
Yashiro
Boehringer Ingelheim Investigational Site
Yazu
Boehringer Ingelheim Investigational Site
Yokkaichi
Boehringer Ingelheim Investigational Site
Yokohama
Boehringer Ingelheim Investigational Site
Yokote
Boehringer Ingelheim Investigational Site
Yoro
Boehringer Ingelheim Investigational Site
Yoshinogawa
Boehringer Ingelheim Investigational Site
Yufu
Boehringer Ingelheim Investigational Site
Zama

Other trials in Japan

About this study

Official title: Pramipexole Special Survey on Long-Term Use

The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.

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.

Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.
Measured: during 18 months

Secondary outcomes (3)

Clinical Global Impression of Improvement
Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Measured: 18 months
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.
Measured: Baseline and at 18 months (or at the time of discontinuation)
Change From Baseline in Modified Hoehn & Yahr Rating Scale
A severity of PD symptom are assessed by Modified Hoehn \& Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).
Measured: Baseline and at 18 months (or at the time of discontinuation)

Timeline

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

Feb 2004Mar 2009

First posted14 Feb 2008 (estimated)
Study startFeb 2004
Primary completionMar 2009

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: 1,645 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615914
Sponsor's protocol ID: 248.547
Status last verified: Jun 2014
First submitted: 31 Jan 2008
Last updated: 11 Jul 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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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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Study at a glance

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

Official title: Pramipexole Special Survey on Long-Term Use
ClinicalTrials.gov ID: NCT00615914
Acronym / sponsor ID: 248.547
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 1,645 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Mar 2009 (actual)
First posted: 14 Feb 2008 (estimated)
Results: Posted 23 Nov 2010

Clinical summary

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

The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Parkinson's disease patients in daily clinical settings

Key inclusion criteria (1 listed)

Patients with Parkinson's disease

Key exclusion criteria (1 listed)

Patients should have been treated according to the Japanese insert slip

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

Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Time frame: during 18 months
The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.

3 secondary outcomes

Clinical Global Impression of Improvement
Time frame: 18 months
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Time frame: Baseline and at 18 months (or at the time of discontinuation)
Change From Baseline in Modified Hoehn & Yahr Rating Scale
Time frame: Baseline and at 18 months (or at the time of discontinuation)

Results and safety

Results posted to the registry on 23 Nov 2010, 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	1,645	1,008

Primary outcome: Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events

Time frame: during 18 months. Number. Unit: percentage of participants

Measure	Pramipexole n = 1553
Proportion of Adverse Events	42.4
Proportion of Adverse Drug Reactions	34.5
Proportion of Serious Adverse Events	7.2

Population analysed: Patients excluded from 1581 patients were: 15 who had no visit since the first prescription, 2 for no treatment, 10 patients who were irregularly enrolled patients (exclusion from analysis according to regulatory requirement) and 1 patient that had no safety data available. As a result, there were 1553 patients in the safety analysis set.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pramipexole	111 of 1,553 (7.1%)	267 of 1,553 (17.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

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

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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)
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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

273 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 273 sites in Japan.

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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 273 sites in Japan. 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 23 Nov 2010). 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?

Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events (time frame: during 18 months). 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 NCT00615914.

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 Jul 2014.