Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa
- Conditions
- Parkinson Disease
- Registration Number
- NCT00613301
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
Patients with Parkinson's disease who do not receive L-Dopa supplementation
Patients should have been treated according to the Japanese insert slip
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events during 36 months The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.
- Secondary Outcome Measures
Name Time Method Clinical Global Impression of Improvement after 36 months treatment Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score Baseline and at 36 months (or at the time of discontinuation) 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.
Change From Baseline in Modified Hoehn & Yahr Rating Scale Baseline and at 36 months (or at the time of discontinuation) 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).
Trial Locations
- Locations (119)
Boehringer Ingelheim Investigational Site 113
🇯🇵Tomiai, Japan
Boehringer Ingelheim Investigational Site 35
🇯🇵Tokyo Ota-ku, Japan
Boehringer Ingelheim Investigational Site 27
🇯🇵Chiba, Japan
Boehringer Ingelheim Investigational Site 56
🇯🇵Gifu, Japan
Boehringer Ingelheim Investigational Site 11
🇯🇵Akita, Japan
Boehringer Ingelheim Investigational Site 105
🇯🇵Fukuoka, Japan
Boehringer Ingelheim Investigational Site 106
🇯🇵Fukuoka, Japan
Boehringer Ingelheim Investigational Site 59
🇯🇵Hamamatsu, Japan
Boehringer Ingelheim Investigational Site 103
🇯🇵Fukuoka, Japan
Boehringer Ingelheim Investigational Site 82
🇯🇵Himeji, Japan
Boehringer Ingelheim Investigational Site 87
🇯🇵Hiroshima, Japan
Boehringer Ingelheim Investigational Site 24
🇯🇵Kawagoe, Japan
Boehringer Ingelheim Investigational Site 46
🇯🇵Kawasaki, Japan
Boehringer Ingelheim Investigational Site 112
🇯🇵Kawatana, Japan
Boehringer Ingelheim Investigational Site 83
🇯🇵Kobe, Japan
Boehringer Ingelheim Investigational Site 9
🇯🇵Morioka, Japan
Boehringer Ingelheim Investigational Site 97
🇯🇵Nangoku, Japan
Boehringer Ingelheim Investigational Site 28
🇯🇵Narita, Japan
Boehringer Ingelheim Investigational Site 109
🇯🇵Togitsu, Japan
Boehringer Ingelheim Investigational Site 79
🇯🇵Sakai, Japan
Boehringer Ingelheim Investigational Site 49
🇯🇵Fujisawa, Japan
Boehringer Ingelheim Investigational Site 107
🇯🇵Kasuga, Japan
Boehringer Ingelheim Investigational Site 111
🇯🇵Kawatana, Japan
Boehringer Ingelheim Investigational Site 63
🇯🇵Konan, Japan
Boehringer Ingelheim Investigational Site 21
🇯🇵Koshiagya, Japan
Boehringer Ingelheim Investigational Site 88
🇯🇵Mihara, Japan
Boehringer Ingelheim Investigational Site 66
🇯🇵Otsu, Japan
Boehringer Ingelheim Investigational Site 22
🇯🇵Saitama, Japan
Boehringer Ingelheim Investigational Site 90
🇯🇵Sanyoonoda, Japan
Boehringer Ingelheim Investigational Site 52
🇯🇵Sanjo, Japan
Boehringer Ingelheim Investigational Site 26
🇯🇵Chiba, Japan
Boehringer Ingelheim Investigational Site 99
🇯🇵Kitakyushu, Japan
Boehringer Ingelheim Investigational Site 117
🇯🇵Kiyotake, Japan
Boehringer Ingelheim Investigational Site 12
🇯🇵Koriyama, Japan
Boehringer Ingelheim Investigational Site 68
🇯🇵Kyoto, Japan
Boehringer Ingelheim Investigational Site 69
🇯🇵Kyoto, Japan
Boehringer Ingelheim Investigational Site 55
🇯🇵Matsumoto, Japan
Boehringer Ingelheim Investigational Site 23
🇯🇵Moroyama, Japan
Boehringer Ingelheim Investigational Site 51
🇯🇵Nagaoka, Japan
Boehringer Ingelheim Investigational Site 62
🇯🇵Nagoya, Japan
Boehringer Ingelheim Investigational Site 81
🇯🇵Nishinomiya, Japan
Boehringer Ingelheim Investigational Site 45
🇯🇵Sagamihara, Japan
Boehringer Ingelheim Investigational Site 6
🇯🇵Sapporo, Japan
Boehringer Ingelheim Investigational Site 74
🇯🇵Takatsuki, Japan
Boehringer Ingelheim Investigational Site 118
🇯🇵Kagoshima, Japan
Boehringer Ingelheim Investigational Site 50
🇯🇵Kashiwazaki, Japan
Boehringer Ingelheim Investigational Site 100
🇯🇵Kurume, Japan
Boehringer Ingelheim Investigational Site 19
🇯🇵Maebashi, Japan
Boehringer Ingelheim Investigational Site 20
🇯🇵Maebashi, Japan
Boehringer Ingelheim Investigational Site 54
🇯🇵Minobu, Japan
Boehringer Ingelheim Investigational Site 116
🇯🇵Miyakonojo, Japan
Boehringer Ingelheim Investigational Site 93
🇯🇵Naruto, Japan
Boehringer Ingelheim Investigational Site 72
🇯🇵Osaka, Japan
Boehringer Ingelheim Investigational Site 7
🇯🇵Sapporo, Japan
Boehringer Ingelheim Investigational Site 85
🇯🇵Shingu, Japan
Boehringer Ingelheim Investigational Site 101
🇯🇵Tagawa, Japan
Boehringer Ingelheim Investigational Site 96
🇯🇵Takamatsu, Japan
Boehringer Ingelheim Investigational Site 30
🇯🇵Tokyo Adachi-ku, Japan
Boehringer Ingelheim Investigational Site 40
🇯🇵Tokyo Bunkyo-ku, Japan
Boehringer Ingelheim Investigational Site 32
🇯🇵Tokyo Itabashi-ku, Japan
Boehringer Ingelheim Investigational Site 33
🇯🇵Tokyo Itabashi-ku, Japan
Boehringer Ingelheim Investigational Site 47
🇯🇵Yokohama, Japan
Boehringer Ingelheim Investigational Site 48
🇯🇵Yokohama, Japan
Boehringer Ingelheim Investigational Site 94
🇯🇵Yoshinogawa, Japan
Boehringer Ingelheim Investigational Site 71
🇯🇵Kyoto, Japan
Boehringer Ingelheim Investigational Site 114
🇯🇵Miyazaki, Japan
Boehringer Ingelheim Investigational Site 108
🇯🇵Saga, Japan
Boehringer Ingelheim Investigational Site 110
🇯🇵Sasebo, Japan
Boehringer Ingelheim Investigational Site 43
🇯🇵Tokyo Meguro-ku, Japan
Boehringer Ingelheim Investigational Site 44
🇯🇵Tokyo Toshima-ku, Japan
Boehringer Ingelheim Investigational Site 16
🇯🇵Tsukuba, Japan
Boehringer Ingelheim Investigational Site 31
🇯🇵Tokyo Arakawa-ku, Japan
Boehringer Ingelheim Investigational Site 38
🇯🇵Tokyo Chiyoda-ku, Japan
Boehringer Ingelheim Investigational Site 39
🇯🇵Tokyo Nakano-ku, Japan
Boehringer Ingelheim Investigational Site 14
🇯🇵Toride, Japan
Boehringer Ingelheim Investigational Site 65
🇯🇵Tsu, Japan
Boehringer Ingelheim Investigational Site 84
🇯🇵Wakayama, Japan
Boehringer Ingelheim Investigational Site 34
🇯🇵Tokyo Ota-ku, Japan
Boehringer Ingelheim Investigational Site 36
🇯🇵Tokyo Shinjuku-ku, Japan
Boehringer Ingelheim Investigational Site 37
🇯🇵Tokyo Shinjuku-ku, Japan
Boehringer Ingelheim Investigational Site 53
🇯🇵Uchinada, Japan
Boehringer Ingelheim Investigational Site 89
🇯🇵Yamaguchi, Japan
Boehringer Ingelheim Investigational Site 25
🇯🇵Fukaya, Japan
Boehringer Ingelheim Investigational Site 95
🇯🇵Anan, Japan
Boehringer Ingelheim Investigational Site 60
🇯🇵Fuji, Japan
Boehringer Ingelheim Investigational Site 104
🇯🇵Fukuoka, Japan
Boehringer Ingelheim Investigational Site 86
🇯🇵Hiroshima, Japan
Boehringer Ingelheim Investigational Site 67
🇯🇵Koga, Japan
Boehringer Ingelheim Investigational Site 13
🇯🇵Koriyama, Japan
Boehringer Ingelheim Investigational Site 80
🇯🇵Habikino, Japan
Boehringer Ingelheim Investigational Site 10
🇯🇵Sendai, Japan
Boehringer Ingelheim Investigational Site 64
🇯🇵Handa, Japan
Boehringer Ingelheim Investigational Site 115
🇯🇵Miyazaki, Japan
Boehringer Ingelheim Investigational Site 4
🇯🇵Muroran, Japan
Boehringer Ingelheim Investigational Site 102
🇯🇵Naoetsu, Japan
Boehringer Ingelheim Investigational Site 119
🇯🇵Nishihara, Japan
Boehringer Ingelheim Investigational Site 91
🇯🇵Shimonoseki, Japan
Boehringer Ingelheim Investigational Site 75
🇯🇵Takatsuki, Japan
Boehringer Ingelheim Investigational Site 92
🇯🇵Tokushima, Japan
Boehringer Ingelheim Investigational Site 18
🇯🇵Shimotsuke, Japan
Boehringer Ingelheim Investigational Site 73
🇯🇵Suita, Japan
Boehringer Ingelheim Investigational Site 57
🇯🇵Shizuoka, Japan
Boehringer Ingelheim Investigational Site 41
🇯🇵Tokyo Bunkyo-ku, Japan
Boehringer Ingelheim Investigational Site 1
🇯🇵Asahikawa, Japan
Boehringer Ingelheim Investigational Site 2
🇯🇵Asahikawa, Japan
Boehringer Ingelheim Investigational Site 3
🇯🇵Hakodate, Japan
Boehringer Ingelheim Investigational Site 76
🇯🇵Hirakata, Japan
Boehringer Ingelheim Investigational Site 8
🇯🇵Ichinoseki, Japan
Boehringer Ingelheim Investigational Site 15
🇯🇵Kamisu, Japan
Boehringer Ingelheim Investigational Site 70
🇯🇵Kyoto, Japan
Boehringer Ingelheim Investigational Site 77
🇯🇵Moriguchi, Japan
Boehringer Ingelheim Investigational Site 61
🇯🇵Nagoya, Japan
Boehringer Ingelheim Investigational Site 78
🇯🇵Osakasayama, Japan
Boehringer Ingelheim Investigational Site 17
🇯🇵Nikko, Japan
Boehringer Ingelheim Investigational Site 98
🇯🇵Okawa, Japan
Boehringer Ingelheim Investigational Site 5
🇯🇵Sapporo, Japan
Boehringer Ingelheim Investigational Site 58
🇯🇵Shizuoka, Japan
Boehringer Ingelheim Investigational Site 42
🇯🇵Tokyo Bunkyo-ku, Japan
Boehringer Ingelheim Investigational Site 29
🇯🇵Urayasu, Japan