Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 119 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 in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the 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: 416 participants
Where: 119 sitesJapan
Study dates: Feb 2004to Sep 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 do not receive L-Dopa supplementation

Who cannot join

Patients should have been treated according to the Japanese insert slip

Trial locations and contacts

119 sites in 1 country.

City, postcode or hospital

119 sites in 1 country

Japan119 sites

Boehringer Ingelheim Investigational Site 11
Akita
Boehringer Ingelheim Investigational Site 95
Anan
Boehringer Ingelheim Investigational Site 1
Asahikawa
Boehringer Ingelheim Investigational Site 2
Asahikawa
Boehringer Ingelheim Investigational Site 26
Chiba
Boehringer Ingelheim Investigational Site 27
Chiba
Boehringer Ingelheim Investigational Site 60
Fuji
Boehringer Ingelheim Investigational Site 49
Fujisawa
Boehringer Ingelheim Investigational Site 25
Fukaya
Boehringer Ingelheim Investigational Site 103
Fukuoka
Boehringer Ingelheim Investigational Site 104
Fukuoka
Boehringer Ingelheim Investigational Site 105
Fukuoka
Boehringer Ingelheim Investigational Site 106
Fukuoka
Boehringer Ingelheim Investigational Site 56
Gifu
Boehringer Ingelheim Investigational Site 80
Habikino
Boehringer Ingelheim Investigational Site 3
Hakodate
Boehringer Ingelheim Investigational Site 59
Hamamatsu
Boehringer Ingelheim Investigational Site 64
Handa
Boehringer Ingelheim Investigational Site 82
Himeji
Boehringer Ingelheim Investigational Site 76
Hirakata
Boehringer Ingelheim Investigational Site 86
Hiroshima
Boehringer Ingelheim Investigational Site 87
Hiroshima
Boehringer Ingelheim Investigational Site 8
Ichinoseki
Boehringer Ingelheim Investigational Site 118
Kagoshima
Boehringer Ingelheim Investigational Site 15
Kamisu
Boehringer Ingelheim Investigational Site 50
Kashiwazaki
Boehringer Ingelheim Investigational Site 107
Kasuga
Boehringer Ingelheim Investigational Site 24
Kawagoe
Boehringer Ingelheim Investigational Site 46
Kawasaki
Boehringer Ingelheim Investigational Site 111
Kawatana
Boehringer Ingelheim Investigational Site 112
Kawatana
Boehringer Ingelheim Investigational Site 99
Kitakyushu
Boehringer Ingelheim Investigational Site 117
Kiyotake
Boehringer Ingelheim Investigational Site 83
Kobe
Boehringer Ingelheim Investigational Site 67
Koga
Boehringer Ingelheim Investigational Site 63
Kōnan
Boehringer Ingelheim Investigational Site 12
Kōriyama
Boehringer Ingelheim Investigational Site 13
Kōriyama
Boehringer Ingelheim Investigational Site 21
Koshiagya
Boehringer Ingelheim Investigational Site 100
Kurume
Boehringer Ingelheim Investigational Site 68
Kyoto
Boehringer Ingelheim Investigational Site 69
Kyoto
Boehringer Ingelheim Investigational Site 70
Kyoto
Boehringer Ingelheim Investigational Site 71
Kyoto
Boehringer Ingelheim Investigational Site 19
Maebashi
Boehringer Ingelheim Investigational Site 20
Maebashi
Boehringer Ingelheim Investigational Site 55
Matsumoto
Boehringer Ingelheim Investigational Site 88
Mihara
Boehringer Ingelheim Investigational Site 54
Minobu
Boehringer Ingelheim Investigational Site 116
Miyakonojō
Boehringer Ingelheim Investigational Site 114
Miyazaki
Boehringer Ingelheim Investigational Site 115
Miyazaki
Boehringer Ingelheim Investigational Site 77
Moriguchi
Boehringer Ingelheim Investigational Site 9
Morioka
Boehringer Ingelheim Investigational Site 23
Morohongō
Boehringer Ingelheim Investigational Site 53
Mukai-awagasaki
Boehringer Ingelheim Investigational Site 4
Muroran
Boehringer Ingelheim Investigational Site 51
Nagaoka
Boehringer Ingelheim Investigational Site 61
Nagoya
Boehringer Ingelheim Investigational Site 62
Nagoya
Boehringer Ingelheim Investigational Site 97
Nangōku
Boehringer Ingelheim Investigational Site 102
Naoetsu
Boehringer Ingelheim Investigational Site 28
Narita
Boehringer Ingelheim Investigational Site 93
Narutō
Boehringer Ingelheim Investigational Site 17
Nikkō
Boehringer Ingelheim Investigational Site 119
Nishihara
Boehringer Ingelheim Investigational Site 81
Nishinomiya
Boehringer Ingelheim Investigational Site 98
Ōkawa
Boehringer Ingelheim Investigational Site 72
Osaka
Boehringer Ingelheim Investigational Site 66
Ōtsu
Boehringer Ingelheim Investigational Site 108
Saga
Boehringer Ingelheim Investigational Site 45
Sagamihara
Boehringer Ingelheim Investigational Site 22
Saitama
Boehringer Ingelheim Investigational Site 79
Sakai
Boehringer Ingelheim Investigational Site 52
Sanjō
Boehringer Ingelheim Investigational Site 90
Sanyōonoda
Boehringer Ingelheim Investigational Site 5
Sapporo
Boehringer Ingelheim Investigational Site 6
Sapporo
Boehringer Ingelheim Investigational Site 7
Sapporo
Boehringer Ingelheim Investigational Site 110
Sasebo
Boehringer Ingelheim Investigational Site 78
Sayama
Boehringer Ingelheim Investigational Site 10
Sendai
Boehringer Ingelheim Investigational Site 91
Shimonoseki
Boehringer Ingelheim Investigational Site 18
Shimotsuke
Boehringer Ingelheim Investigational Site 85
Shingū
Boehringer Ingelheim Investigational Site 57
Shizuoka
Boehringer Ingelheim Investigational Site 58
Shizuoka
Boehringer Ingelheim Investigational Site 73
Suita
Boehringer Ingelheim Investigational Site 101
Tagawa
Boehringer Ingelheim Investigational Site 96
Takamatsu
Boehringer Ingelheim Investigational Site 74
Takatsuki
Boehringer Ingelheim Investigational Site 75
Takatsuki
Boehringer Ingelheim Investigational Site 109
Togitsu
Boehringer Ingelheim Investigational Site 92
Tokushima
Boehringer Ingelheim Investigational Site 30
Tokyo Adachi-ku
Boehringer Ingelheim Investigational Site 31
Tokyo Arakawa-ku
Boehringer Ingelheim Investigational Site 40
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site 41
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site 42
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site 38
Tokyo Chiyoda-ku
Boehringer Ingelheim Investigational Site 32
Tokyo Itabashi-ku
Boehringer Ingelheim Investigational Site 33
Tokyo Itabashi-ku
Boehringer Ingelheim Investigational Site 43
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site 39
Tokyo Nakano-ku
Boehringer Ingelheim Investigational Site 34
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site 35
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site 36
Tokyo Shinjuku-ku
Boehringer Ingelheim Investigational Site 37
Tokyo Shinjuku-ku
Boehringer Ingelheim Investigational Site 44
Tokyo Toshima-ku
Boehringer Ingelheim Investigational Site 113
Tomiai
Boehringer Ingelheim Investigational Site 14
Toride
Boehringer Ingelheim Investigational Site 65
Tsu
Boehringer Ingelheim Investigational Site 16
Tsukuba
Boehringer Ingelheim Investigational Site 29
Urayasu
Boehringer Ingelheim Investigational Site 84
Wakayama
Boehringer Ingelheim Investigational Site 89
Yamaguchi
Boehringer Ingelheim Investigational Site 47
Yokohama
Boehringer Ingelheim Investigational Site 48
Yokohama
Boehringer Ingelheim Investigational Site 94
Yoshinogawa

Other trials in Japan

About this study

Official title: Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa

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 safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.
Measured: during 36 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: after 36 months treatment
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 36 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 36 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 2004Sep 2009

First posted13 Feb 2008 (estimated)
Study startFeb 2004
Primary completionSep 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: 416 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00613301
Sponsor's protocol ID: 248.549
Status last verified: May 2014
First submitted: 31 Jan 2008
Last updated: 6 Jun 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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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa
ClinicalTrials.gov ID: NCT00613301
Acronym / sponsor ID: 248.549
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 416 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Sep 2009 (actual)
First posted: 13 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.

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 who do not receive L-Dopa supplementation

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 36 months
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.

3 secondary outcomes

Clinical Global Impression of Improvement
Time frame: after 36 months treatment
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Time frame: Baseline and at 36 months (or at the time of discontinuation)
Change From Baseline in Modified Hoehn & Yahr Rating Scale
Time frame: Baseline and at 36 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	416	188

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

Time frame: during 36 months. Number. Unit: Proportion (percentage of participants)

Measure	Pramipexole n = 346
Proportion of Adverse Events	51.7
Proportion of Adverse Drug Reactions	41.3
Proportion of Serious Adverse Events	8.4

Population analysed: 364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 patients in the safety analysis set.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pramipexole	29 of 346 (8.4%)	106 of 346 (30.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 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)
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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

119 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 119 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 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 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 36 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 NCT00613301.

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 6 Jun 2014.