Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 118 sites in Japan.

Completed

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

Trial summary

Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease. Read more about this study

Who is it for?: Any age
Conditions the study is for: Parkinson Disease
What is being tested?: Mirapex LA
How many people: 615 participants
Where: 118 sitesJapan
Study dates: Feb 2012to Jun 2014
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: 600

Who may be able to join

Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.

Who cannot join

None

Trial locations and contacts

118 sites in 1 country.

City, postcode or hospital

118 sites in 1 country

Japan118 sites

Boehringer Ingelheim Investigational Site 28
Abiko,Chiba
Boehringer Ingelheim Investigational Site 86
Akashi,Hyogo
Boehringer Ingelheim Investigational Site 13
Akita,Akita
Boehringer Ingelheim Investigational Site 9
Aomori,Aomori
Boehringer Ingelheim Investigational Site 2
Asahikawa,Hokkaido
Boehringer Ingelheim Investigational Site 36
Bunkyo,Tokyo
Boehringer Ingelheim Investigational Site 35
Chuo,Tokyo
Boehringer Ingelheim Investigational Site 40
Chuo,Tokyo
Boehringer Ingelheim Investigational Site 54
Chuo,Yamanashi
Boehringer Ingelheim Investigational Site 6
Date,Hokkaido
Boehringer Ingelheim Investigational Site 34
Edogawa,Tokyo
Boehringer Ingelheim Investigational Site 32
Fuchu,Tokyo
Boehringer Ingelheim Investigational Site 22
Fujioka,Gunma
Boehringer Ingelheim Investigational Site 46
Fujisawa,Kanagawa
Boehringer Ingelheim Investigational Site 48
Fujisawa,Kanagawa
Boehringer Ingelheim Investigational Site 24
Fukaya,Saitama
Boehringer Ingelheim Investigational Site 53
Fukui,Fukui
Boehringer Ingelheim Investigational Site 105
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 106
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 109
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 16
Fukushima,Fukushima
Boehringer Ingelheim Investigational Site 60
Gifu,Gifu
Boehringer Ingelheim Investigational Site 44
Hadano,Kanagawa
Boehringer Ingelheim Investigational Site 62
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 96
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 97
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 78
Ibaraki,Osaka
Boehringer Ingelheim Investigational Site 29
Ichihara,Chiba
Boehringer Ingelheim Investigational Site 68
Ichinomiya,Aichi
Boehringer Ingelheim Investigational Site 57
Iida,Nagano
Boehringer Ingelheim Investigational Site 108
Iiduka,Fukuoka
Boehringer Ingelheim Investigational Site 88
Ikoma,Nara
Boehringer Ingelheim Investigational Site 103
Imabari,Ehime
Boehringer Ingelheim Investigational Site 17
Iwaki,Fukushima
Boehringer Ingelheim Investigational Site 3
Iwamizawa,Hokkaido
Boehringer Ingelheim Investigational Site 117
Kirishima,Kagoshima
Boehringer Ingelheim Investigational Site 111
Kitakyushu,Fukuoka
Boehringer Ingelheim Investigational Site 5
Kitami,Hokkaido
Boehringer Ingelheim Investigational Site 55
Kofu,Yamanashi
Boehringer Ingelheim Investigational Site 70
Konan,Aichi
Boehringer Ingelheim Investigational Site 27
Koshigaya,Saitama
Boehringer Ingelheim Investigational Site 114
Kumamoto,Kumamoto
Boehringer Ingelheim Investigational Site 107
Kurume,Fukuoka
Boehringer Ingelheim Investigational Site 77
Kyoto,Kyoto
Boehringer Ingelheim Investigational Site 23
Maebashi,Gunma
Boehringer Ingelheim Investigational Site 42
Minato,Tokyo
Boehringer Ingelheim Investigational Site 116
Miyakonojo,Miyazaki
Boehringer Ingelheim Investigational Site 66
Miyoshi,Aichi
Boehringer Ingelheim Investigational Site 10
Morioka,Iwate
Boehringer Ingelheim Investigational Site 74
Moriyama,Shiga
Boehringer Ingelheim Investigational Site 4
Muroran,Hokkaido
Boehringer Ingelheim Investigational Site 56
Nagano,Nagano
Boehringer Ingelheim Investigational Site 30
Nagareyama,Chiba
Boehringer Ingelheim Investigational Site 113
Nagasaki,Nagasaki
Boehringer Ingelheim Investigational Site 65
Nagoya,Aichi
Boehringer Ingelheim Investigational Site 67
Nagoya,Aichi
Boehringer Ingelheim Investigational Site 52
Nanao,Ishikawa
Boehringer Ingelheim Investigational Site 104
Nangoku,Kouchi
Boehringer Ingelheim Investigational Site 50
Niigata,Niigata
Boehringer Ingelheim Investigational Site 85
Nishinomiya,Hyogo
Boehringer Ingelheim Investigational Site 72
Obu,Aichi
Boehringer Ingelheim Investigational Site 61
Ogaki,Gifu
Boehringer Ingelheim Investigational Site 92
Ohta,Shimane
Boehringer Ingelheim Investigational Site 115
Oita,Oita
Boehringer Ingelheim Investigational Site 93
Okayama,Okayama
Boehringer Ingelheim Investigational Site 95
Okayama,Okayama
Boehringer Ingelheim Investigational Site 118
Okinawa,Okinawa
Boehringer Ingelheim Investigational Site 110
Onojo,Fukuoka
Boehringer Ingelheim Investigational Site 80
Osaka,Osaka
Boehringer Ingelheim Investigational Site 81
Osaka,Osaka
Boehringer Ingelheim Investigational Site 82
Osaka,Osaka
Boehringer Ingelheim Investigational Site 38
Ota,Tokyo
Boehringer Ingelheim Investigational Site 75
Otsu,Shiga
Boehringer Ingelheim Investigational Site 76
Otsu,Shiga
Boehringer Ingelheim Investigational Site 18
Ryugasaki,Ibaragi
Boehringer Ingelheim Investigational Site 43
Sagamihara,Kanagawa
Boehringer Ingelheim Investigational Site 47
Sagamihara,Kanagawa
Boehringer Ingelheim Investigational Site 25
Saitama,Saitama
Boehringer Ingelheim Investigational Site 26
Saitama,Saitama
Boehringer Ingelheim Investigational Site 79
Sakai,Osaka
Boehringer Ingelheim Investigational Site 83
Sakai,Osaka
Boehringer Ingelheim Investigational Site 102
Sakaide,Kagawa
Boehringer Ingelheim Investigational Site 58
Saku,Nagano
Boehringer Ingelheim Investigational Site 31
Sakura,Chiba
Boehringer Ingelheim Investigational Site 98
Sanyōonoda
Boehringer Ingelheim Investigational Site 1
Sapporo,Hokkaido
Boehringer Ingelheim Investigational Site 7
Sapporo,Hokkaido
Boehringer Ingelheim Investigational Site 8
Sapporo,Hokkaido
Boehringer Ingelheim Investigational Site 59
Sekigahara,Gifu
Boehringer Ingelheim Investigational Site 11
Sendai,Miyagi
Boehringer Ingelheim Investigational Site 12
Sendai,Miyagi
Boehringer Ingelheim Investigational Site 33
Setagaya,Tokyo
Boehringer Ingelheim Investigational Site 69
Seto,Aichi
Boehringer Ingelheim Investigational Site 63
Shimoda,Shizuoka
Boehringer Ingelheim Investigational Site 64
Shimoda,Shizuoka
Boehringer Ingelheim Investigational Site 99
Shimonoseki,Yamaguchi
Boehringer Ingelheim Investigational Site 20
Shimotsuke,Tochigi
Boehringer Ingelheim Investigational Site 21
Shimotsuke,Tochigi
Boehringer Ingelheim Investigational Site 90
Shingu,Wakayama
Boehringer Ingelheim Investigational Site 37
Shinjuku,Tokyo
Boehringer Ingelheim Investigational Site 39
Shinjuku,Tokyo
Boehringer Ingelheim Investigational Site 41
Shinjuku,Tokyo
Boehringer Ingelheim Investigational Site 51
Takaoka,Toyama
Boehringer Ingelheim Investigational Site 101
Tokushima,Tokushima
Boehringer Ingelheim Investigational Site 112
Tosu,Saga
Boehringer Ingelheim Investigational Site 71
Toyokawa,Aichi
Boehringer Ingelheim Investigational Site 84
Toyonaka,Osaka
Boehringer Ingelheim Investigational Site 87
Toyooka,Hyogo
Boehringer Ingelheim Investigational Site 73
Tsu,Mie
Boehringer Ingelheim Investigational Site 19
Tsukuba,Ibaragi
Boehringer Ingelheim Investigational Site 94
Tsukubo,Okayama
Boehringer Ingelheim Investigational Site 15
Tsuruoka,Yamagata
Boehringer Ingelheim Investigational Site 89
Wakayama,Wakayama
Boehringer Ingelheim Investigational Site 91
Yazu,Tottori
Boehringer Ingelheim Investigational Site 45
Yokohama,Kanagawa
Boehringer Ingelheim Investigational Site 49
Yokohama,Kanagawa
Boehringer Ingelheim Investigational Site 14
Yokote,Akita
Boehringer Ingelheim Investigational Site 100
Yoshinogawa,Tokushima

Other trials in Japan

About this study

Official title: Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.

Conditions: Parkinson Disease
Being tested: Mirapex LA
Medical subject headings: Parkinson Disease

What participants receive

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

Mirapex LADrug
Pramipexole Hydrochloride Hydrate

Study groups in NCT01525641
Study group	Role	What they receive
Patient with Parkinson's Disease		Not described Receives: Drug: Mirapex LA

What is being measured

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

Percentage of Adverse Drug Reactions
Percentage of subjects with adverse drug reactions
Measured: From baseline up to week 52

Secondary outcomes (5)

Clinical Global Impression of Effect
Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.
Measured: Week 52
Change From Baseline in Total Score of the UPDRS Part III to Last Observation
Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score.
UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status.
The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.
The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia.
Measured: Baseline and week 52
Change From Baseline in the Modified Hoehn & Yahr to Last Observation
Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.
Measured: Baseline and week 52
Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - "on" - to a sudden inability to move - "off".
Measured: Week 52
Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA
Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.
Measured: Week 52

Timeline

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

Feb 2012Jun 2014

First posted3 Feb 2012 (estimated)
Study startFeb 2012
Primary completionJun 2014
Study completionJun 2014

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: Prospective
Enrolment: 615 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01525641
Sponsor's protocol ID: 248.680
Status last verified: Jul 2015
First submitted: 1 Feb 2012
Last updated: 14 Aug 2015
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 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT01525641
Acronym / sponsor ID: 248.680
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 615 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 3 Feb 2012 (estimated)
Results: Posted 14 Aug 2015

Clinical summary

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

Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patient with Parkinson's Disease	–	Drug: Mirapex LA

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 600

Key inclusion criteria (1 listed)

Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.

Key exclusion criteria (1 listed)

None

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
Mirapex LAPramipexole Hydrochloride Hydrate	Drug	Patient with Parkinson's Disease

Primary outcome

Percentage of Adverse Drug Reactions
Time frame: From baseline up to week 52
Percentage of subjects with adverse drug reactions

5 secondary outcomes

Clinical Global Impression of Effect
Time frame: Week 52
Change From Baseline in Total Score of the UPDRS Part III to Last Observation
Time frame: Baseline and week 52
Change From Baseline in the Modified Hoehn & Yahr to Last Observation
Time frame: Baseline and week 52
Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
Time frame: Week 52
Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA
Time frame: Week 52

Results and safety

Results posted to the registry on 14 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects With Parkinson's Disease (PD)	615	435

Primary outcome: Percentage of Adverse Drug Reactions

Time frame: From baseline up to week 52. Number. Unit: percentage of participants

Measure	Subjects With Parkinson's Disease (PD) n = 569
Value	24.78

Population analysed: Safety set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline upto Week 52.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With Parkinson's Disease (PD)	30 of 569 (5.3%)	35 of 569 (6.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Parkinson Disease

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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

118 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 118 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 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 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 14 Aug 2015). 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?

Percentage of Adverse Drug Reactions (time frame: From baseline up to week 52). 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 NCT01525641.

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 14 Aug 2015.