Post Marketing Surveillance of Mirapex LA on the Long-term Use
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01525641
First received: February 1, 2012
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
In Japan, post-approval execution of post-marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for re-examination. Reexamination period is defined by the J-PAL Four years after approval of new dosage form, results of PMS need to be submitted as a part of re-examination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare.
| Condition | Intervention |
|---|---|
|
Parkinson Disease |
Drug: Mirapex LA |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Post Marketing Survey on Long Term Drug Use of Mirapex LA Tablets in Patients With Parkinson's Disease |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Proportion of adverse drug reactions [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
- Proportion of serious adverse events [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical global impression of effect [ Time Frame: up to 52 weeks ]
- Change from baseline in total score of the UPDRS Part III to last observation [ Time Frame: up to 52 weeks ]
- Change from baseline in the Modified Hoehn & Yahr to last observation [ Time Frame: up to 52 weeks ]
- Proportion of following AEs of special interest -Sudden onset of sleep -Somnolence -Neuroleptic malignant syndrome -Hallucination -Delusion -Delirium -Agitation -Confusion -Dyspepsia -Dry mouth -Constipation -Vomiting -Abnormal behaviour [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
- Onset or offset of on and off/wearing-off phenomenon in patients with concomitant L-DOPA [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 600 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patient with Parkinson's Disease |
Drug: Mirapex LA
Pramipexole Hydrochloride Hydrate
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
600
Criteria
Inclusion criteria:
- Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.
Exclusion criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525641
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| Japan | |
| Boehringer Ingelheim Investigational Site 28 | |
| Abiko,Chiba, Japan | |
| Boehringer Ingelheim Investigational Site 86 | |
| Akashi,Hyogo, Japan | |
| Boehringer Ingelheim Investigational Site 13 | |
| Akita,Akita, Japan | |
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| Aomori,Aomori, Japan | |
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| Asahikawa,Hokkaido, Japan | |
| Boehringer Ingelheim Investigational Site 36 | |
| Bunkyo,Tokyo, Japan | |
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| Chuo,Tokyo, Japan | |
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| Chuo,Tokyo, Japan | |
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| Chuo,Yamanashi, Japan | |
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| Date,Hokkaido, Japan | |
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| Edogawa,Tokyo, Japan | |
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| Fuchu,Tokyo, Japan | |
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| Fujioka,Gunma, Japan | |
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| Fujisawa,Kanagawa, Japan | |
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| Fukaya,Saitama, Japan | |
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| Fukushima,Fukushima, Japan | |
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| Gifu,Gifu, Japan | |
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| Hadano,Kanagawa, Japan | |
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| Hamamatsu,Shizuoka, Japan | |
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| Hiroshima,Hiroshima, Japan | |
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| Ibaraki,Osaka, Japan | |
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| Ichihara,Chiba, Japan | |
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| Ichinomiya,Aichi, Japan | |
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| Iida,Nagano, Japan | |
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| Iiduka,Fukuoka, Japan | |
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| Ikoma,Nara, Japan | |
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| Imabari,Ehime, Japan | |
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| Iwaki,Fukushima, Japan | |
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| Iwamizawa,Hokkaido, Japan | |
| Boehringer Ingelheim Investigational Site 117 | |
| Kirishima,Kagoshima, Japan | |
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| Kitakyushu,Fukuoka, Japan | |
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| Kitami,Hokkaido, Japan | |
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| Kofu,Yamanashi, Japan | |
| Boehringer Ingelheim Investigational Site 70 | |
| Konan,Aichi, Japan | |
| Boehringer Ingelheim Investigational Site 27 | |
| Koshigaya,Saitama, Japan | |
| Boehringer Ingelheim Investigational Site 114 | |
| Kumamoto,Kumamoto, Japan | |
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| Kurume,Fukuoka, Japan | |
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| Kyoto,Kyoto, Japan | |
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| Maebashi,Gunma, Japan | |
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| Minato,Tokyo, Japan | |
| Boehringer Ingelheim Investigational Site 116 | |
| Miyakonojo,Miyazaki, Japan | |
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| Miyoshi,Aichi, Japan | |
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| Morioka,Iwate, Japan | |
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| Moriyama,Shiga, Japan | |
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| Nagareyama,Chiba, Japan | |
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| Nangoku,Kouchi, Japan | |
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| Niigata,Niigata, Japan | |
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| Nishinomiya,Hyogo, Japan | |
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| Obu,Aichi, Japan | |
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| Ogaki,Gifu, Japan | |
| Boehringer Ingelheim Investigational Site 92 | |
| Ohta,Shimane, Japan | |
| Boehringer Ingelheim Investigational Site 115 | |
| Oita,Oita, Japan | |
| Boehringer Ingelheim Investigational Site 95 | |
| Okayama,Okayama, Japan | |
| Boehringer Ingelheim Investigational Site 93 | |
| Okayama,Okayama, Japan | |
| Boehringer Ingelheim Investigational Site 118 | |
| Okinawa,Okinawa, Japan | |
| Boehringer Ingelheim Investigational Site 110 | |
| Onojo,Fukuoka, Japan | |
| Boehringer Ingelheim Investigational Site 82 | |
| Osaka,Osaka, Japan | |
| Boehringer Ingelheim Investigational Site 80 | |
| Osaka,Osaka, Japan | |
| Boehringer Ingelheim Investigational Site 81 | |
| Osaka,Osaka, Japan | |
| Boehringer Ingelheim Investigational Site 38 | |
| Ota,Tokyo, Japan | |
| Boehringer Ingelheim Investigational Site 75 | |
| Otsu,Shiga, Japan | |
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| Otsu,Shiga, Japan | |
| Boehringer Ingelheim Investigational Site 18 | |
| Ryugasaki,Ibaragi, Japan | |
| Boehringer Ingelheim Investigational Site 47 | |
| Sagamihara,Kanagawa, Japan | |
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| Sagamihara,Kanagawa, Japan | |
| Boehringer Ingelheim Investigational Site 26 | |
| Saitama,Saitama, Japan | |
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| Sakai,Osaka, Japan | |
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| Saku,Nagano, Japan | |
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| Sakura,Chiba, Japan | |
| Boehringer Ingelheim Investigational Site 98 | |
| Sanyo-Onoda, Japan | |
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| Sapporo,Hokkaido, Japan | |
| Boehringer Ingelheim Investigational Site 1 | |
| Sapporo,Hokkaido, Japan | |
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| Sapporo,Hokkaido, Japan | |
| Boehringer Ingelheim Investigational Site 59 | |
| Sekigahara,Gifu, Japan | |
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| Sendai,Miyagi, Japan | |
| Boehringer Ingelheim Investigational Site 12 | |
| Sendai,Miyagi, Japan | |
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| Setagaya,Tokyo, Japan | |
| Boehringer Ingelheim Investigational Site 69 | |
| Seto,Aichi, Japan | |
| Boehringer Ingelheim Investigational Site 63 | |
| Shimoda,Shizuoka, Japan | |
| Boehringer Ingelheim Investigational Site 64 | |
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| Boehringer Ingelheim Investigational Site 99 | |
| Shimonoseki,Yamaguchi, Japan | |
| Boehringer Ingelheim Investigational Site 20 | |
| Shimotsuke,Tochigi, Japan | |
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| Shimotsuke,Tochigi, Japan | |
| Boehringer Ingelheim Investigational Site 90 | |
| Shingu,Wakayama, Japan | |
| Boehringer Ingelheim Investigational Site 37 | |
| Shinjuku,Tokyo, Japan | |
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| Boehringer Ingelheim Investigational Site 39 | |
| Shinjuku,Tokyo, Japan | |
| Boehringer Ingelheim Investigational Site 51 | |
| Takaoka,Toyama, Japan | |
| Boehringer Ingelheim Investigational Site 101 | |
| Tokushima,Tokushima, Japan | |
| Boehringer Ingelheim Investigational Site 112 | |
| Tosu,Saga, Japan | |
| Boehringer Ingelheim Investigational Site 71 | |
| Toyokawa,Aichi, Japan | |
| Boehringer Ingelheim Investigational Site 84 | |
| Toyonaka,Osaka, Japan | |
| Boehringer Ingelheim Investigational Site 87 | |
| Toyooka,Hyogo, Japan | |
| Boehringer Ingelheim Investigational Site 73 | |
| Tsu,Mie, Japan | |
| Boehringer Ingelheim Investigational Site 19 | |
| Tsukuba,Ibaragi, Japan | |
| Boehringer Ingelheim Investigational Site 94 | |
| Tsukubo,Okayama, Japan | |
| Boehringer Ingelheim Investigational Site 15 | |
| Tsuruoka,Yamagata, Japan | |
| Boehringer Ingelheim Investigational Site 89 | |
| Wakayama,Wakayama, Japan | |
| Boehringer Ingelheim Investigational Site 91 | |
| Yazu,Tottori, Japan | |
| Boehringer Ingelheim Investigational Site 45 | |
| Yokohama,Kanagawa, Japan | |
| Boehringer Ingelheim Investigational Site 49 | |
| Yokohama,Kanagawa, Japan | |
| Boehringer Ingelheim Investigational Site 14 | |
| Yokote,Akita, Japan | |
| Boehringer Ingelheim Investigational Site 100 | |
| Yoshinogawa,Tokushima, Japan | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01525641 History of Changes |
| Other Study ID Numbers: | 248.680 |
| Study First Received: | February 1, 2012 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pramipexol Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 16, 2013