Parkinson Disease Clinical Trial
Official title:
Pramipexole Special Survey on Long-Term Use
| NCT number | NCT00615914 |
| Other study ID # | 248.547 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | January 31, 2008 |
| Last updated | June 10, 2014 |
| Start date | February 2004 |
| Verified date | June 2014 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1645 |
| Est. completion date | |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: Patients with Parkinson's disease Exclusion Criteria: Patients should have been treated according to the Japanese insert slip |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Boehringer Ingelheim Investigational Site | Agano | |
| Japan | Boehringer Ingelheim Investigational Site | Aizuwakamatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Akashi | |
| Japan | Boehringer Ingelheim Investigational Site | Akita | |
| Japan | Boehringer Ingelheim Investigational Site | Asahikawa | |
| Japan | Boehringer Ingelheim Investigational Site | Asakura | |
| Japan | Boehringer Ingelheim Investigational Site | Ayagawa | |
| Japan | Boehringer Ingelheim Investigational Site | Azumino | |
| Japan | Boehringer Ingelheim Investigational Site | Bando | |
| Japan | Boehringer Ingelheim Investigational Site | Beppu | |
| Japan | Boehringer Ingelheim Investigational Site | Bihoro | |
| Japan | Boehringer Ingelheim Investigational Site | Chiba | |
| Japan | Boehringer Ingelheim Investigational Site | Chikusei | |
| Japan | Boehringer Ingelheim Investigational Site | Chuo | |
| Japan | Boehringer Ingelheim Investigational Site | Date | |
| Japan | Boehringer Ingelheim Investigational Site | Ebetsu | |
| Japan | Boehringer Ingelheim Investigational Site | Ebina | |
| Japan | Boehringer Ingelheim Investigational Site | Eiheiji | |
| Japan | Boehringer Ingelheim Investigational Site | Fuchu | |
| Japan | Boehringer Ingelheim Investigational Site | Fuji | |
| Japan | Boehringer Ingelheim Investigational Site | Fujieda | |
| Japan | Boehringer Ingelheim Investigational Site | Fujinomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Fujioka | |
| Japan | Boehringer Ingelheim Investigational Site | Fujisawa | |
| Japan | Boehringer Ingelheim Investigational Site | Fujiyoshida | |
| Japan | Boehringer Ingelheim Investigational Site | Fukaya | |
| Japan | Boehringer Ingelheim Investigational Site | Fukui | |
| Japan | Boehringer Ingelheim Investigational Site | Fukuoka | |
| Japan | Boehringer Ingelheim Investigational Site | Fukushima | |
| Japan | Boehringer Ingelheim Investigational Site | Fukuyama | |
| Japan | Boehringer Ingelheim Investigational Site | Geisei | |
| Japan | Boehringer Ingelheim Investigational Site | Gifu | |
| Japan | Boehringer Ingelheim Investigational Site | Ginowan | |
| Japan | Boehringer Ingelheim Investigational Site | Hachinohe | |
| Japan | Boehringer Ingelheim Investigational Site | Hadano | |
| Japan | Boehringer Ingelheim Investigational Site | Haebaru | |
| Japan | Boehringer Ingelheim Investigational Site | Hagahama | |
| Japan | Boehringer Ingelheim Investigational Site | Hakodate | |
| Japan | Boehringer Ingelheim Investigational Site | Hamada | |
| Japan | Boehringer Ingelheim Investigational Site | Hamamatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Hayashima | |
| Japan | Boehringer Ingelheim Investigational Site | Higashimurayama | |
| Japan | Boehringer Ingelheim Investigational Site | Higashiosaka | |
| Japan | Boehringer Ingelheim Investigational Site | Higashiyamato | |
| Japan | Boehringer Ingelheim Investigational Site | Himeji | |
| Japan | Boehringer Ingelheim Investigational Site | Hiratsuka | |
| Japan | Boehringer Ingelheim Investigational Site | Hirokawa | |
| Japan | Boehringer Ingelheim Investigational Site | Hirosaki | |
| Japan | Boehringer Ingelheim Investigational Site | Hiroshima | |
| Japan | Boehringer Ingelheim Investigational Site | Hita | |
| Japan | Boehringer Ingelheim Investigational Site | Hofu | |
| Japan | Boehringer Ingelheim Investigational Site | Ibaragi | |
| Japan | Boehringer Ingelheim Investigational Site | Ichikikushikino | |
| Japan | Boehringer Ingelheim Investigational Site | Ichinomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Ichinoseki | |
| Japan | Boehringer Ingelheim Investigational Site | Iizuka | |
| Japan | Boehringer Ingelheim Investigational Site | Ikeda | |
| Japan | Boehringer Ingelheim Investigational Site | Ikoma | |
| Japan | Boehringer Ingelheim Investigational Site | Ina | |
| Japan | Boehringer Ingelheim Investigational Site | Inazawa | |
| Japan | Boehringer Ingelheim Investigational Site | Inba | |
| Japan | Boehringer Ingelheim Investigational Site | Inuyama | |
| Japan | Boehringer Ingelheim Investigational Site | Isezaki | |
| Japan | Boehringer Ingelheim Investigational Site | Itoigawa | |
| Japan | Boehringer Ingelheim Investigational Site | Iwaki | |
| Japan | Boehringer Ingelheim Investigational Site | Iwata | |
| Japan | Boehringer Ingelheim Investigational Site | Joetsu | |
| Japan | Boehringer Ingelheim Investigational Site | Kagoshima | |
| Japan | Boehringer Ingelheim Investigational Site | Kahoku | |
| Japan | Boehringer Ingelheim Investigational Site | Kajiki | |
| Japan | Boehringer Ingelheim Investigational Site | Kakegawa | |
| Japan | Boehringer Ingelheim Investigational Site | Kakogawa | |
| Japan | Boehringer Ingelheim Investigational Site | Kamisu | |
| Japan | Boehringer Ingelheim Investigational Site | Kamogawa | |
| Japan | Boehringer Ingelheim Investigational Site | Kanazawa | |
| Japan | Boehringer Ingelheim Investigational Site | Kannonji | |
| Japan | Boehringer Ingelheim Investigational Site | Karatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Kashima | |
| Japan | Boehringer Ingelheim Investigational Site | Kashiwa | |
| Japan | Boehringer Ingelheim Investigational Site | Kashiwazaki | |
| Japan | Boehringer Ingelheim Investigational Site | Kasukabe | |
| Japan | Boehringer Ingelheim Investigational Site | Kato | |
| Japan | Boehringer Ingelheim Investigational Site | Kawagoe | |
| Japan | Boehringer Ingelheim Investigational Site | Kawasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Kawatana | |
| Japan | Boehringer Ingelheim Investigational Site | Kikugawa | |
| Japan | Boehringer Ingelheim Investigational Site | Kirishima | |
| Japan | Boehringer Ingelheim Investigational Site | Kitakyushu | |
| Japan | Boehringer Ingelheim Investigational Site | Kiyose | |
| Japan | Boehringer Ingelheim Investigational Site | Kiyotake | |
| Japan | Boehringer Ingelheim Investigational Site | Kizugawa | |
| Japan | Boehringer Ingelheim Investigational Site | Kobayashi | |
| Japan | Boehringer Ingelheim Investigational Site | Kobe | |
| Japan | Boehringer Ingelheim Investigational Site | Kochi | |
| Japan | Boehringer Ingelheim Investigational Site | Kodaira | |
| Japan | Boehringer Ingelheim Investigational Site | Kofu | |
| Japan | Boehringer Ingelheim Investigational Site | Koga | |
| Japan | Boehringer Ingelheim Investigational Site | Kokubunji | |
| Japan | Boehringer Ingelheim Investigational Site | Komae | |
| Japan | Boehringer Ingelheim Investigational Site | Komatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Komoro | |
| Japan | Boehringer Ingelheim Investigational Site | Koriyama | |
| Japan | Boehringer Ingelheim Investigational Site | Koshi | |
| Japan | Boehringer Ingelheim Investigational Site | Koshigawa | |
| Japan | Boehringer Ingelheim Investigational Site | Kumamoto | |
| Japan | Boehringer Ingelheim Investigational Site | Kurashiki | |
| Japan | Boehringer Ingelheim Investigational Site | Kurayoshi | |
| Japan | Boehringer Ingelheim Investigational Site | Kure | |
| Japan | Boehringer Ingelheim Investigational Site | Kurume | |
| Japan | Boehringer Ingelheim Investigational Site | Kushiro | |
| Japan | Boehringer Ingelheim Investigational Site | Kutchan | |
| Japan | Boehringer Ingelheim Investigational Site | Kuwana | |
| Japan | Boehringer Ingelheim Investigational Site | Kyonan | |
| Japan | Boehringer Ingelheim Investigational Site | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site | Maebaru | |
| Japan | Boehringer Ingelheim Investigational Site | Maebashi | |
| Japan | Boehringer Ingelheim Investigational Site | Maibara | |
| Japan | Boehringer Ingelheim Investigational Site | Maizuru | |
| Japan | Boehringer Ingelheim Investigational Site | Marugame | |
| Japan | Boehringer Ingelheim Investigational Site | Matsuda | |
| Japan | Boehringer Ingelheim Investigational Site | Matsudo | |
| Japan | Boehringer Ingelheim Investigational Site | Matsue | |
| Japan | Boehringer Ingelheim Investigational Site | Matsumoto | |
| Japan | Boehringer Ingelheim Investigational Site | Matsuyama | |
| Japan | Boehringer Ingelheim Investigational Site | Mibu | |
| Japan | Boehringer Ingelheim Investigational Site | Mihara | |
| Japan | Boehringer Ingelheim Investigational Site | Miki | |
| Japan | Boehringer Ingelheim Investigational Site | Minakami | |
| Japan | Boehringer Ingelheim Investigational Site | Minamata | |
| Japan | Boehringer Ingelheim Investigational Site | Minobu | |
| Japan | Boehringer Ingelheim Investigational Site | Misashino | |
| Japan | Boehringer Ingelheim Investigational Site | Mito | |
| Japan | Boehringer Ingelheim Investigational Site | Miyaki | |
| Japan | Boehringer Ingelheim Investigational Site | Miyakonojo | |
| Japan | Boehringer Ingelheim Investigational Site | Miyazaki | |
| Japan | Boehringer Ingelheim Investigational Site | Mooka | |
| Japan | Boehringer Ingelheim Investigational Site | Moriguchi | |
| Japan | Boehringer Ingelheim Investigational Site | Morioka | |
| Japan | Boehringer Ingelheim Investigational Site | Moriya | |
| Japan | Boehringer Ingelheim Investigational Site | Moriyama | |
| Japan | Boehringer Ingelheim Investigational Site | Muroran | |
| Japan | Boehringer Ingelheim Investigational Site | Nagakute | |
| Japan | Boehringer Ingelheim Investigational Site | Nagaoka | |
| Japan | Boehringer Ingelheim Investigational Site | Nagaokakyo | |
| Japan | Boehringer Ingelheim Investigational Site | Nagasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Nagoya | |
| Japan | Boehringer Ingelheim Investigational Site | Nangoku | |
| Japan | Boehringer Ingelheim Investigational Site | Nara | |
| Japan | Boehringer Ingelheim Investigational Site | Narita | |
| Japan | Boehringer Ingelheim Investigational Site | Naruto | |
| Japan | Boehringer Ingelheim Investigational Site | Nichinan | |
| Japan | Boehringer Ingelheim Investigational Site | Niigata | |
| Japan | Boehringer Ingelheim Investigational Site | Niihama | |
| Japan | Boehringer Ingelheim Investigational Site | Nikko | |
| Japan | Boehringer Ingelheim Investigational Site | Nishigo | |
| Japan | Boehringer Ingelheim Investigational Site | Nishihara | |
| Japan | Boehringer Ingelheim Investigational Site | Nishinomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Nishio | |
| Japan | Boehringer Ingelheim Investigational Site | Nishitokyo | |
| Japan | Boehringer Ingelheim Investigational Site | Nobeoka | |
| Japan | Boehringer Ingelheim Investigational Site | Noboribetsu | |
| Japan | Boehringer Ingelheim Investigational Site | Numazu | |
| Japan | Boehringer Ingelheim Investigational Site | Obama | |
| Japan | Boehringer Ingelheim Investigational Site | Obihiro | |
| Japan | Boehringer Ingelheim Investigational Site | Odate | |
| Japan | Boehringer Ingelheim Investigational Site | Odawara | |
| Japan | Boehringer Ingelheim Investigational Site | Ofunato | |
| Japan | Boehringer Ingelheim Investigational Site | Ogaki | |
| Japan | Boehringer Ingelheim Investigational Site | Ohzu | |
| Japan | Boehringer Ingelheim Investigational Site | Oiso | |
| Japan | Boehringer Ingelheim Investigational Site | Oita | |
| Japan | Boehringer Ingelheim Investigational Site | Ojiya | |
| Japan | Boehringer Ingelheim Investigational Site | Okawa | |
| Japan | Boehringer Ingelheim Investigational Site | Okayama | |
| Japan | Boehringer Ingelheim Investigational Site | Omaezaki | |
| Japan | Boehringer Ingelheim Investigational Site | Omura | |
| Japan | Boehringer Ingelheim Investigational Site | Omuta | |
| Japan | Boehringer Ingelheim Investigational Site | Onga | |
| Japan | Boehringer Ingelheim Investigational Site | Onojo | |
| Japan | Boehringer Ingelheim Investigational Site | Onomichi | |
| Japan | Boehringer Ingelheim Investigational Site | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site | Otsu | |
| Japan | Boehringer Ingelheim Investigational Site | Ozu | |
| Japan | Boehringer Ingelheim Investigational Site | Sado | |
| Japan | Boehringer Ingelheim Investigational Site | Saga | |
| Japan | Boehringer Ingelheim Investigational Site | Sagamihara | |
| Japan | Boehringer Ingelheim Investigational Site | Saitama | |
| Japan | Boehringer Ingelheim Investigational Site | Sakai | |
| Japan | Boehringer Ingelheim Investigational Site | Sakaide | |
| Japan | Boehringer Ingelheim Investigational Site | Sakata | |
| Japan | Boehringer Ingelheim Investigational Site | Saku | |
| Japan | Boehringer Ingelheim Investigational Site | Sanjo | |
| Japan | Boehringer Ingelheim Investigational Site | Sano | |
| Japan | Boehringer Ingelheim Investigational Site | Sanyoonoda | |
| Japan | Boehringer Ingelheim Investigational Site | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site | Sasebo | |
| Japan | Boehringer Ingelheim Investigational Site | Seijo | |
| Japan | Boehringer Ingelheim Investigational Site | Sendai | |
| Japan | Boehringer Ingelheim Investigational Site | Shimabara | |
| Japan | Boehringer Ingelheim Investigational Site | Shimonoseki | |
| Japan | Boehringer Ingelheim Investigational Site | Shimotsuke | |
| Japan | Boehringer Ingelheim Investigational Site | Shingu | |
| Japan | Boehringer Ingelheim Investigational Site | Shinshiro | |
| Japan | Boehringer Ingelheim Investigational Site | Shizuoka | |
| Japan | Boehringer Ingelheim Investigational Site | Shunan | |
| Japan | Boehringer Ingelheim Investigational Site | Soo | |
| Japan | Boehringer Ingelheim Investigational Site | Suita | |
| Japan | Boehringer Ingelheim Investigational Site | Tajimi | |
| Japan | Boehringer Ingelheim Investigational Site | Takamatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Takanabe | |
| Japan | Boehringer Ingelheim Investigational Site | Takaoka | |
| Japan | Boehringer Ingelheim Investigational Site | Takasago | |
| Japan | Boehringer Ingelheim Investigational Site | Takasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Takatsuki | |
| Japan | Boehringer Ingelheim Investigational Site | Takehara | |
| Japan | Boehringer Ingelheim Investigational Site | Toda | |
| Japan | Boehringer Ingelheim Investigational Site | Togitsu | |
| Japan | Boehringer Ingelheim Investigational Site | Tokoname | |
| Japan | Boehringer Ingelheim Investigational Site | Tokushima | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Adachi-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Bunkyo-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Chiyoda-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Edogawa-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Itabashi-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Katsushika-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Kita-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Meguro-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Minayo-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Nakano-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Nerima-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Ota-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Setagaya-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Shinagawa-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Shinjuku-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Suginami-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Toshima-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tomakomai | |
| Japan | Boehringer Ingelheim Investigational Site | Tomiai | |
| Japan | Boehringer Ingelheim Investigational Site | Tondabayashi | |
| Japan | Boehringer Ingelheim Investigational Site | Toon | |
| Japan | Boehringer Ingelheim Investigational Site | Toride | |
| Japan | Boehringer Ingelheim Investigational Site | Toyama | |
| Japan | Boehringer Ingelheim Investigational Site | Toyoake | |
| Japan | Boehringer Ingelheim Investigational Site | Toyokawa | |
| Japan | Boehringer Ingelheim Investigational Site | Toyonaka | |
| Japan | Boehringer Ingelheim Investigational Site | Toyooka | |
| Japan | Boehringer Ingelheim Investigational Site | Tsu | |
| Japan | Boehringer Ingelheim Investigational Site | Tsubata | |
| Japan | Boehringer Ingelheim Investigational Site | Tsuchiura | |
| Japan | Boehringer Ingelheim Investigational Site | Tsukuba | |
| Japan | Boehringer Ingelheim Investigational Site | Tsuruoka | |
| Japan | Boehringer Ingelheim Investigational Site | Uchinada | |
| Japan | Boehringer Ingelheim Investigational Site | Ueda | |
| Japan | Boehringer Ingelheim Investigational Site | Uji | |
| Japan | Boehringer Ingelheim Investigational Site | Ujo | |
| Japan | Boehringer Ingelheim Investigational Site | Urayasu | |
| Japan | Boehringer Ingelheim Investigational Site | Uruma | |
| Japan | Boehringer Ingelheim Investigational Site | Utsunomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Wakayama | |
| Japan | Boehringer Ingelheim Investigational Site | Yamagata | |
| Japan | Boehringer Ingelheim Investigational Site | Yamaguchi | |
| Japan | Boehringer Ingelheim Investigational Site | Yamamoto | |
| Japan | Boehringer Ingelheim Investigational Site | Yanai | |
| Japan | Boehringer Ingelheim Investigational Site | Yao | |
| Japan | Boehringer Ingelheim Investigational Site | Yashiro | |
| Japan | Boehringer Ingelheim Investigational Site | Yazu | |
| Japan | Boehringer Ingelheim Investigational Site | Yokkaichi | |
| Japan | Boehringer Ingelheim Investigational Site | Yokohama | |
| Japan | Boehringer Ingelheim Investigational Site | Yokote | |
| Japan | Boehringer Ingelheim Investigational Site | Yoro | |
| Japan | Boehringer Ingelheim Investigational Site | Yoshinogawa | |
| Japan | Boehringer Ingelheim Investigational Site | Yufu | |
| Japan | Boehringer Ingelheim Investigational Site | Zama |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | during 18 months | No |
| Secondary | 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). | 18 months | No |
| Secondary | 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. | Baseline and at 18 months (or at the time of discontinuation) | No |
| Secondary | 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). | Baseline and at 18 months (or at the time of discontinuation) | No |
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