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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson Disease

Intervention: Mirapex LA (Drug)

Phase: N/A

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Percentage of Adverse Drug Reactions

Secondary outcome:

Clinical Global Impression of Effect

Change From Baseline in Total Score of the UPDRS Part III to Last Observation

Change From Baseline in the Modified Hoehn & Yahr to Last Observation

Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA

Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Boehringer Ingelheim Investigational Site 28, Abiko,Chiba, Japan

Boehringer Ingelheim Investigational Site 86, Akashi,Hyogo, Japan

Boehringer Ingelheim Investigational Site 13, Akita,Akita, Japan

Boehringer Ingelheim Investigational Site 9, Aomori,Aomori, Japan

Boehringer Ingelheim Investigational Site 2, Asahikawa,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 36, Bunkyo,Tokyo, Japan

Boehringer Ingelheim Investigational Site 35, Chuo,Tokyo, Japan

Boehringer Ingelheim Investigational Site 40, Chuo,Tokyo, Japan

Boehringer Ingelheim Investigational Site 54, Chuo,Yamanashi, Japan

Boehringer Ingelheim Investigational Site 6, Date,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 34, Edogawa,Tokyo, Japan

Boehringer Ingelheim Investigational Site 32, Fuchu,Tokyo, Japan

Boehringer Ingelheim Investigational Site 22, Fujioka,Gunma, Japan

Boehringer Ingelheim Investigational Site 46, Fujisawa,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 48, Fujisawa,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 24, Fukaya,Saitama, Japan

Boehringer Ingelheim Investigational Site 53, Fukui,Fukui, Japan

Boehringer Ingelheim Investigational Site 105, Fukuoka,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 106, Fukuoka,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 109, Fukuoka,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 16, Fukushima,Fukushima, Japan

Boehringer Ingelheim Investigational Site 60, Gifu,Gifu, Japan

Boehringer Ingelheim Investigational Site 44, Hadano,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 62, Hamamatsu,Shizuoka, Japan

Boehringer Ingelheim Investigational Site 96, Hiroshima,Hiroshima, Japan

Boehringer Ingelheim Investigational Site 97, Hiroshima,Hiroshima, Japan

Boehringer Ingelheim Investigational Site 78, Ibaraki,Osaka, Japan

Boehringer Ingelheim Investigational Site 29, Ichihara,Chiba, Japan

Boehringer Ingelheim Investigational Site 68, Ichinomiya,Aichi, Japan

Boehringer Ingelheim Investigational Site 57, Iida,Nagano, Japan

Boehringer Ingelheim Investigational Site 108, Iiduka,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 88, Ikoma,Nara, Japan

Boehringer Ingelheim Investigational Site 103, Imabari,Ehime, Japan

Boehringer Ingelheim Investigational Site 17, Iwaki,Fukushima, Japan

Boehringer Ingelheim Investigational Site 3, Iwamizawa,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 117, Kirishima,Kagoshima, Japan

Boehringer Ingelheim Investigational Site 111, Kitakyushu,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 5, Kitami,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 55, 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

Boehringer Ingelheim Investigational Site 107, Kurume,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 77, Kyoto,Kyoto, Japan

Boehringer Ingelheim Investigational Site 23, Maebashi,Gunma, Japan

Boehringer Ingelheim Investigational Site 42, Minato,Tokyo, Japan

Boehringer Ingelheim Investigational Site 116, Miyakonojo,Miyazaki, Japan

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Boehringer Ingelheim Investigational Site 56, Nagano,Nagano, Japan

Boehringer Ingelheim Investigational Site 30, Nagareyama,Chiba, Japan

Boehringer Ingelheim Investigational Site 113, Nagasaki,Nagasaki, Japan

Boehringer Ingelheim Investigational Site 65, Nagoya,Aichi, Japan

Boehringer Ingelheim Investigational Site 67, Nagoya,Aichi, Japan

Boehringer Ingelheim Investigational Site 52, Nanao,Ishikawa, Japan

Boehringer Ingelheim Investigational Site 104, Nangoku,Kouchi, Japan

Boehringer Ingelheim Investigational Site 50, Niigata,Niigata, Japan

Boehringer Ingelheim Investigational Site 85, Nishinomiya,Hyogo, Japan

Boehringer Ingelheim Investigational Site 72, Obu,Aichi, Japan

Boehringer Ingelheim Investigational Site 61, Ogaki,Gifu, Japan

Boehringer Ingelheim Investigational Site 92, Ohta,Shimane, Japan

Boehringer Ingelheim Investigational Site 115, Oita,Oita, Japan

Boehringer Ingelheim Investigational Site 93, Okayama,Okayama, Japan

Boehringer Ingelheim Investigational Site 95, Okayama,Okayama, Japan

Boehringer Ingelheim Investigational Site 118, Okinawa,Okinawa, Japan

Boehringer Ingelheim Investigational Site 110, Onojo,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 80, Osaka,Osaka, Japan

Boehringer Ingelheim Investigational Site 81, Osaka,Osaka, Japan

Boehringer Ingelheim Investigational Site 82, Osaka,Osaka, Japan

Boehringer Ingelheim Investigational Site 38, Ota,Tokyo, Japan

Boehringer Ingelheim Investigational Site 75, Otsu,Shiga, Japan

Boehringer Ingelheim Investigational Site 76, Otsu,Shiga, Japan

Boehringer Ingelheim Investigational Site 18, Ryugasaki,Ibaragi, Japan

Boehringer Ingelheim Investigational Site 43, Sagamihara,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 47, Sagamihara,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 25, Saitama,Saitama, Japan

Boehringer Ingelheim Investigational Site 26, Saitama,Saitama, Japan

Boehringer Ingelheim Investigational Site 79, Sakai,Osaka, Japan

Boehringer Ingelheim Investigational Site 83, Sakai,Osaka, Japan

Boehringer Ingelheim Investigational Site 102, Sakaide,Kagawa, Japan

Boehringer Ingelheim Investigational Site 58, Saku,Nagano, Japan

Boehringer Ingelheim Investigational Site 31, Sakura,Chiba, Japan

Boehringer Ingelheim Investigational Site 98, Sanyo-Onoda, Japan

Boehringer Ingelheim Investigational Site 1, Sapporo,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 7, Sapporo,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 8, Sapporo,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 59, Sekigahara,Gifu, Japan

Boehringer Ingelheim Investigational Site 11, Sendai,Miyagi, Japan

Boehringer Ingelheim Investigational Site 12, Sendai,Miyagi, Japan

Boehringer Ingelheim Investigational Site 33, Setagaya,Tokyo, Japan

Boehringer Ingelheim Investigational Site 69, Seto,Aichi, Japan

Boehringer Ingelheim Investigational Site 63, Shimoda,Shizuoka, Japan

Boehringer Ingelheim Investigational Site 64, Shimoda,Shizuoka, Japan

Boehringer Ingelheim Investigational Site 99, Shimonoseki,Yamaguchi, Japan

Boehringer Ingelheim Investigational Site 20, Shimotsuke,Tochigi, Japan

Boehringer Ingelheim Investigational Site 21, Shimotsuke,Tochigi, Japan

Boehringer Ingelheim Investigational Site 90, Shingu,Wakayama, Japan

Boehringer Ingelheim Investigational Site 37, Shinjuku,Tokyo, Japan

Boehringer Ingelheim Investigational Site 39, Shinjuku,Tokyo, Japan

Boehringer Ingelheim Investigational Site 41, 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

Additional Information

Starting date: February 2012
Last updated: July 17, 2015

Page last updated: August 23, 2015

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