Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole
Pramipexole Special Survey on Long-Term Use
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Kontakty a umístění
Studijní místa
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Agano, Japonsko
- Boehringer Ingelheim Investigational Site
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Aizuwakamatsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Akashi, Japonsko
- Boehringer Ingelheim Investigational Site
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Akita, Japonsko
- Boehringer Ingelheim Investigational Site
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Asahikawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Asakura, Japonsko
- Boehringer Ingelheim Investigational Site
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Ayagawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Azumino, Japonsko
- Boehringer Ingelheim Investigational Site
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Bando, Japonsko
- Boehringer Ingelheim Investigational Site
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Beppu, Japonsko
- Boehringer Ingelheim Investigational Site
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Bihoro, Japonsko
- Boehringer Ingelheim Investigational Site
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Chiba, Japonsko
- Boehringer Ingelheim Investigational Site
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Chikusei, Japonsko
- Boehringer Ingelheim Investigational Site
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Chuo, Japonsko
- Boehringer Ingelheim Investigational Site
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Date, Japonsko
- Boehringer Ingelheim Investigational Site
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Ebetsu, Japonsko
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Ebina, Japonsko
- Boehringer Ingelheim Investigational Site
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Eiheiji, Japonsko
- Boehringer Ingelheim Investigational Site
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Fuchu, Japonsko
- Boehringer Ingelheim Investigational Site
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Fuji, Japonsko
- Boehringer Ingelheim Investigational Site
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Fujieda, Japonsko
- Boehringer Ingelheim Investigational Site
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Fujinomiya, Japonsko
- Boehringer Ingelheim Investigational Site
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Fujioka, Japonsko
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Fujisawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Fujiyoshida, Japonsko
- Boehringer Ingelheim Investigational Site
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Fukaya, Japonsko
- Boehringer Ingelheim Investigational Site
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Fukui, Japonsko
- Boehringer Ingelheim Investigational Site
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Fukuoka, Japonsko
- Boehringer Ingelheim Investigational Site
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Fukushima, Japonsko
- Boehringer Ingelheim Investigational Site
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Fukuyama, Japonsko
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Geisei, Japonsko
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Gifu, Japonsko
- Boehringer Ingelheim Investigational Site
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Ginowan, Japonsko
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Hachinohe, Japonsko
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Hadano, Japonsko
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Haebaru, Japonsko
- Boehringer Ingelheim Investigational Site
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Hagahama, Japonsko
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Hakodate, Japonsko
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Hamada, Japonsko
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Hamamatsu, Japonsko
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Hayashima, Japonsko
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Higashimurayama, Japonsko
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Higashiosaka, Japonsko
- Boehringer Ingelheim Investigational Site
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Higashiyamato, Japonsko
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Himeji, Japonsko
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Hiratsuka, Japonsko
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Hirokawa, Japonsko
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Hirosaki, Japonsko
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Hiroshima, Japonsko
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Hita, Japonsko
- Boehringer Ingelheim Investigational Site
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Hofu, Japonsko
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Ibaragi, Japonsko
- Boehringer Ingelheim Investigational Site
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Ichikikushikino, Japonsko
- Boehringer Ingelheim Investigational Site
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Ichinomiya, Japonsko
- Boehringer Ingelheim Investigational Site
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Ichinoseki, Japonsko
- Boehringer Ingelheim Investigational Site
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Iizuka, Japonsko
- Boehringer Ingelheim Investigational Site
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Ikeda, Japonsko
- Boehringer Ingelheim Investigational Site
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Ikoma, Japonsko
- Boehringer Ingelheim Investigational Site
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Ina, Japonsko
- Boehringer Ingelheim Investigational Site
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Inazawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Inba, Japonsko
- Boehringer Ingelheim Investigational Site
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Inuyama, Japonsko
- Boehringer Ingelheim Investigational Site
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Isezaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Itoigawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Iwaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Iwata, Japonsko
- Boehringer Ingelheim Investigational Site
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Joetsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Kagoshima, Japonsko
- Boehringer Ingelheim Investigational Site
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Kahoku, Japonsko
- Boehringer Ingelheim Investigational Site
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Kajiki, Japonsko
- Boehringer Ingelheim Investigational Site
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Kakegawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Kakogawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Kamisu, Japonsko
- Boehringer Ingelheim Investigational Site
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Kamogawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Kanazawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Kannonji, Japonsko
- Boehringer Ingelheim Investigational Site
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Karatsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Kashima, Japonsko
- Boehringer Ingelheim Investigational Site
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Kashiwa, Japonsko
- Boehringer Ingelheim Investigational Site
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Kashiwazaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Kasukabe, Japonsko
- Boehringer Ingelheim Investigational Site
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Kato, Japonsko
- Boehringer Ingelheim Investigational Site
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Kawagoe, Japonsko
- Boehringer Ingelheim Investigational Site
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Kawasaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Kawatana, Japonsko
- Boehringer Ingelheim Investigational Site
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Kikugawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Kirishima, Japonsko
- Boehringer Ingelheim Investigational Site
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Kitakyushu, Japonsko
- Boehringer Ingelheim Investigational Site
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Kiyose, Japonsko
- Boehringer Ingelheim Investigational Site
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Kiyotake, Japonsko
- Boehringer Ingelheim Investigational Site
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Kizugawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Kobayashi, Japonsko
- Boehringer Ingelheim Investigational Site
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Kobe, Japonsko
- Boehringer Ingelheim Investigational Site
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Kochi, Japonsko
- Boehringer Ingelheim Investigational Site
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Kodaira, Japonsko
- Boehringer Ingelheim Investigational Site
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Kofu, Japonsko
- Boehringer Ingelheim Investigational Site
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Koga, Japonsko
- Boehringer Ingelheim Investigational Site
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Kokubunji, Japonsko
- Boehringer Ingelheim Investigational Site
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Komae, Japonsko
- Boehringer Ingelheim Investigational Site
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Komatsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Komoro, Japonsko
- Boehringer Ingelheim Investigational Site
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Koriyama, Japonsko
- Boehringer Ingelheim Investigational Site
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Koshi, Japonsko
- Boehringer Ingelheim Investigational Site
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Koshigawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Kumamoto, Japonsko
- Boehringer Ingelheim Investigational Site
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Kurashiki, Japonsko
- Boehringer Ingelheim Investigational Site
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Kurayoshi, Japonsko
- Boehringer Ingelheim Investigational Site
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Kure, Japonsko
- Boehringer Ingelheim Investigational Site
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Kurume, Japonsko
- Boehringer Ingelheim Investigational Site
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Kushiro, Japonsko
- Boehringer Ingelheim Investigational Site
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Kutchan, Japonsko
- Boehringer Ingelheim Investigational Site
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Kuwana, Japonsko
- Boehringer Ingelheim Investigational Site
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Kyonan, Japonsko
- Boehringer Ingelheim Investigational Site
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Kyoto, Japonsko
- Boehringer Ingelheim Investigational Site
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Maebaru, Japonsko
- Boehringer Ingelheim Investigational Site
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Maebashi, Japonsko
- Boehringer Ingelheim Investigational Site
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Maibara, Japonsko
- Boehringer Ingelheim Investigational Site
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Maizuru, Japonsko
- Boehringer Ingelheim Investigational Site
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Marugame, Japonsko
- Boehringer Ingelheim Investigational Site
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Matsuda, Japonsko
- Boehringer Ingelheim Investigational Site
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Matsudo, Japonsko
- Boehringer Ingelheim Investigational Site
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Matsue, Japonsko
- Boehringer Ingelheim Investigational Site
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Matsumoto, Japonsko
- Boehringer Ingelheim Investigational Site
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Matsuyama, Japonsko
- Boehringer Ingelheim Investigational Site
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Mibu, Japonsko
- Boehringer Ingelheim Investigational Site
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Mihara, Japonsko
- Boehringer Ingelheim Investigational Site
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Miki, Japonsko
- Boehringer Ingelheim Investigational Site
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Minakami, Japonsko
- Boehringer Ingelheim Investigational Site
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Minamata, Japonsko
- Boehringer Ingelheim Investigational Site
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Minobu, Japonsko
- Boehringer Ingelheim Investigational Site
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Misashino, Japonsko
- Boehringer Ingelheim Investigational Site
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Mito, Japonsko
- Boehringer Ingelheim Investigational Site
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Miyaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Miyakonojo, Japonsko
- Boehringer Ingelheim Investigational Site
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Miyazaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Mooka, Japonsko
- Boehringer Ingelheim Investigational Site
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Moriguchi, Japonsko
- Boehringer Ingelheim Investigational Site
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Morioka, Japonsko
- Boehringer Ingelheim Investigational Site
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Moriya, Japonsko
- Boehringer Ingelheim Investigational Site
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Moriyama, Japonsko
- Boehringer Ingelheim Investigational Site
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Muroran, Japonsko
- Boehringer Ingelheim Investigational Site
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Nagakute, Japonsko
- Boehringer Ingelheim Investigational Site
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Nagaoka, Japonsko
- Boehringer Ingelheim Investigational Site
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Nagaokakyo, Japonsko
- Boehringer Ingelheim Investigational Site
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Nagasaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Nagoya, Japonsko
- Boehringer Ingelheim Investigational Site
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Nangoku, Japonsko
- Boehringer Ingelheim Investigational Site
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Nara, Japonsko
- Boehringer Ingelheim Investigational Site
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Narita, Japonsko
- Boehringer Ingelheim Investigational Site
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Naruto, Japonsko
- Boehringer Ingelheim Investigational Site
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Nichinan, Japonsko
- Boehringer Ingelheim Investigational Site
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Niigata, Japonsko
- Boehringer Ingelheim Investigational Site
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Niihama, Japonsko
- Boehringer Ingelheim Investigational Site
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Nikko, Japonsko
- Boehringer Ingelheim Investigational Site
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Nishigo, Japonsko
- Boehringer Ingelheim Investigational Site
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Nishihara, Japonsko
- Boehringer Ingelheim Investigational Site
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Nishinomiya, Japonsko
- Boehringer Ingelheim Investigational Site
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Nishio, Japonsko
- Boehringer Ingelheim Investigational Site
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Nishitokyo, Japonsko
- Boehringer Ingelheim Investigational Site
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Nobeoka, Japonsko
- Boehringer Ingelheim Investigational Site
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Noboribetsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Numazu, Japonsko
- Boehringer Ingelheim Investigational Site
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Obama, Japonsko
- Boehringer Ingelheim Investigational Site
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Obihiro, Japonsko
- Boehringer Ingelheim Investigational Site
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Odate, Japonsko
- Boehringer Ingelheim Investigational Site
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Odawara, Japonsko
- Boehringer Ingelheim Investigational Site
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Ofunato, Japonsko
- Boehringer Ingelheim Investigational Site
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Ogaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Ohzu, Japonsko
- Boehringer Ingelheim Investigational Site
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Oiso, Japonsko
- Boehringer Ingelheim Investigational Site
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Oita, Japonsko
- Boehringer Ingelheim Investigational Site
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Ojiya, Japonsko
- Boehringer Ingelheim Investigational Site
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Okawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Okayama, Japonsko
- Boehringer Ingelheim Investigational Site
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Omaezaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Omura, Japonsko
- Boehringer Ingelheim Investigational Site
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Omuta, Japonsko
- Boehringer Ingelheim Investigational Site
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Onga, Japonsko
- Boehringer Ingelheim Investigational Site
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Onojo, Japonsko
- Boehringer Ingelheim Investigational Site
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Onomichi, Japonsko
- Boehringer Ingelheim Investigational Site
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Osaka, Japonsko
- Boehringer Ingelheim Investigational Site
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Otsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Ozu, Japonsko
- Boehringer Ingelheim Investigational Site
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Sado, Japonsko
- Boehringer Ingelheim Investigational Site
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Saga, Japonsko
- Boehringer Ingelheim Investigational Site
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Sagamihara, Japonsko
- Boehringer Ingelheim Investigational Site
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Saitama, Japonsko
- Boehringer Ingelheim Investigational Site
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Sakai, Japonsko
- Boehringer Ingelheim Investigational Site
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Sakaide, Japonsko
- Boehringer Ingelheim Investigational Site
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Sakata, Japonsko
- Boehringer Ingelheim Investigational Site
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Saku, Japonsko
- Boehringer Ingelheim Investigational Site
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Sanjo, Japonsko
- Boehringer Ingelheim Investigational Site
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Sano, Japonsko
- Boehringer Ingelheim Investigational Site
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Sanyoonoda, Japonsko
- Boehringer Ingelheim Investigational Site
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Sapporo, Japonsko
- Boehringer Ingelheim Investigational Site
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Sasebo, Japonsko
- Boehringer Ingelheim Investigational Site
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Seijo, Japonsko
- Boehringer Ingelheim Investigational Site
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Sendai, Japonsko
- Boehringer Ingelheim Investigational Site
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Shimabara, Japonsko
- Boehringer Ingelheim Investigational Site
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Shimonoseki, Japonsko
- Boehringer Ingelheim Investigational Site
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Shimotsuke, Japonsko
- Boehringer Ingelheim Investigational Site
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Shingu, Japonsko
- Boehringer Ingelheim Investigational Site
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Shinshiro, Japonsko
- Boehringer Ingelheim Investigational Site
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Shizuoka, Japonsko
- Boehringer Ingelheim Investigational Site
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Shunan, Japonsko
- Boehringer Ingelheim Investigational Site
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Soo, Japonsko
- Boehringer Ingelheim Investigational Site
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Suita, Japonsko
- Boehringer Ingelheim Investigational Site
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Tajimi, Japonsko
- Boehringer Ingelheim Investigational Site
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Takamatsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Takanabe, Japonsko
- Boehringer Ingelheim Investigational Site
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Takaoka, Japonsko
- Boehringer Ingelheim Investigational Site
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Takasago, Japonsko
- Boehringer Ingelheim Investigational Site
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Takasaki, Japonsko
- Boehringer Ingelheim Investigational Site
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Takatsuki, Japonsko
- Boehringer Ingelheim Investigational Site
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Takehara, Japonsko
- Boehringer Ingelheim Investigational Site
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Toda, Japonsko
- Boehringer Ingelheim Investigational Site
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Togitsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokoname, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokushima, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Adachi-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Bunkyo-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Chiyoda-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Edogawa-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Itabashi-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Katsushika-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Kita-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Meguro-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Minayo-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Nakano-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Nerima-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Ota-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Setagaya-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Shinagawa-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Shinjuku-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Suginami-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tokyo Toshima-ku, Japonsko
- Boehringer Ingelheim Investigational Site
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Tomakomai, Japonsko
- Boehringer Ingelheim Investigational Site
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Tomiai, Japonsko
- Boehringer Ingelheim Investigational Site
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Tondabayashi, Japonsko
- Boehringer Ingelheim Investigational Site
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Toon, Japonsko
- Boehringer Ingelheim Investigational Site
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Toride, Japonsko
- Boehringer Ingelheim Investigational Site
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Toyama, Japonsko
- Boehringer Ingelheim Investigational Site
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Toyoake, Japonsko
- Boehringer Ingelheim Investigational Site
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Toyokawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Toyonaka, Japonsko
- Boehringer Ingelheim Investigational Site
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Toyooka, Japonsko
- Boehringer Ingelheim Investigational Site
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Tsu, Japonsko
- Boehringer Ingelheim Investigational Site
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Tsubata, Japonsko
- Boehringer Ingelheim Investigational Site
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Tsuchiura, Japonsko
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Tsukuba, Japonsko
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Tsuruoka, Japonsko
- Boehringer Ingelheim Investigational Site
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Uchinada, Japonsko
- Boehringer Ingelheim Investigational Site
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Ueda, Japonsko
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Uji, Japonsko
- Boehringer Ingelheim Investigational Site
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Ujo, Japonsko
- Boehringer Ingelheim Investigational Site
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Urayasu, Japonsko
- Boehringer Ingelheim Investigational Site
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Uruma, Japonsko
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Utsunomiya, Japonsko
- Boehringer Ingelheim Investigational Site
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Wakayama, Japonsko
- Boehringer Ingelheim Investigational Site
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Yamagata, Japonsko
- Boehringer Ingelheim Investigational Site
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Yamaguchi, Japonsko
- Boehringer Ingelheim Investigational Site
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Yamamoto, Japonsko
- Boehringer Ingelheim Investigational Site
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Yanai, Japonsko
- Boehringer Ingelheim Investigational Site
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Yao, Japonsko
- Boehringer Ingelheim Investigational Site
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Yashiro, Japonsko
- Boehringer Ingelheim Investigational Site
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Yazu, Japonsko
- Boehringer Ingelheim Investigational Site
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Yokkaichi, Japonsko
- Boehringer Ingelheim Investigational Site
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Yokohama, Japonsko
- Boehringer Ingelheim Investigational Site
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Yokote, Japonsko
- Boehringer Ingelheim Investigational Site
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Yoro, Japonsko
- Boehringer Ingelheim Investigational Site
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Yoshinogawa, Japonsko
- Boehringer Ingelheim Investigational Site
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Yufu, Japonsko
- Boehringer Ingelheim Investigational Site
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Zama, Japonsko
- Boehringer Ingelheim Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Patients with Parkinson's disease
Exclusion Criteria:
Patients should have been treated according to the Japanese insert slip
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Časové okno: during 18 months
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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.
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during 18 months
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinical Global Impression of Improvement
Časové okno: 18 months
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Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
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18 months
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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Časové okno: Baseline and at 18 months (or at the time of discontinuation)
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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.
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Baseline and at 18 months (or at the time of discontinuation)
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Change From Baseline in Modified Hoehn & Yahr Rating Scale
Časové okno: Baseline and at 18 months (or at the time of discontinuation)
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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).
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Baseline and at 18 months (or at the time of discontinuation)
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 248.547
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .