Clinical trial NCT00613301: Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa
Official title: Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 416
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease patients in daily clinical settings

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.


Eligibility criteria: Inclusion Criteria:

Patients with Parkinson's disease who do not receive L-Dopa supplementation

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip

Primary outcomes:
measure: Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
timeFrame: during 36 months
Secondary outcomes:
measure: Clinical Global Impression of Improvement
timeFrame: after 36 months treatment
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
timeFrame: Baseline and at 36 months (or at the time of discontinuation)
measure: Change From Baseline in Modified Hoehn & Yahr Rating Scale
timeFrame: Baseline and at 36 months (or at the time of discontinuation)
Other outcomes:
Locations:
city: Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 11
city: Anan
country: Japan
facility: Boehringer Ingelheim Investigational Site 95
city: Asahikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Asahikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 26
city: Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 27
city: Fujisawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 49
city: Fuji
country: Japan
facility: Boehringer Ingelheim Investigational Site 60
city: Fukaya
country: Japan
facility: Boehringer Ingelheim Investigational Site 25
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 103
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 104
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 105
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 106
city: Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 56
city: Habikino
country: Japan
facility: Boehringer Ingelheim Investigational Site 80
city: Hakodate
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Hamamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 59
city: Handa
country: Japan
facility: Boehringer Ingelheim Investigational Site 64
city: Himeji
country: Japan
facility: Boehringer Ingelheim Investigational Site 82
city: Hirakata
country: Japan
facility: Boehringer Ingelheim Investigational Site 76
city: Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 86
city: Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 87
city: Ichinoseki
country: Japan
facility: Boehringer Ingelheim Investigational Site 8
city: Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 118
city: Kamisu
country: Japan
facility: Boehringer Ingelheim Investigational Site 15
city: Kashiwazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 50
city: Kasuga
country: Japan
facility: Boehringer Ingelheim Investigational Site 107
city: Kawagoe
country: Japan
facility: Boehringer Ingelheim Investigational Site 24
city: Kawasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 46
city: Kawatana
country: Japan
facility: Boehringer Ingelheim Investigational Site 111
city: Kawatana
country: Japan
facility: Boehringer Ingelheim Investigational Site 112
city: Kitakyushu
country: Japan
facility: Boehringer Ingelheim Investigational Site 99
city: Kiyotake
country: Japan
facility: Boehringer Ingelheim Investigational Site 117
city: Kobe
country: Japan
facility: Boehringer Ingelheim Investigational Site 83
city: Koga
country: Japan
facility: Boehringer Ingelheim Investigational Site 67
city: Konan
country: Japan
facility: Boehringer Ingelheim Investigational Site 63
city: Koriyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 12
city: Koriyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 13
city: Koshiagya
country: Japan
facility: Boehringer Ingelheim Investigational Site 21
city: Kurume
country: Japan
facility: Boehringer Ingelheim Investigational Site 100
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 68
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 69
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 70
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 71
city: Maebashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 19
city: Maebashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 20
city: Matsumoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 55
city: Mihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 88
city: Minobu
country: Japan
facility: Boehringer Ingelheim Investigational Site 54
city: Miyakonojo
country: Japan
facility: Boehringer Ingelheim Investigational Site 116
city: Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 114
city: Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 115
city: Moriguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 77
city: Morioka
country: Japan
facility: Boehringer Ingelheim Investigational Site 9
city: Moroyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 23
city: Muroran
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Nagaoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 51
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 61
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 62
city: Nangoku
country: Japan
facility: Boehringer Ingelheim Investigational Site 97
city: Naoetsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 102
city: Narita
country: Japan
facility: Boehringer Ingelheim Investigational Site 28
city: Naruto
country: Japan
facility: Boehringer Ingelheim Investigational Site 93
city: Nikko
country: Japan
facility: Boehringer Ingelheim Investigational Site 17
city: Nishihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 119
city: Nishinomiya
country: Japan
facility: Boehringer Ingelheim Investigational Site 81
city: Okawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 98
city: Osakasayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 78
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 72
city: Otsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 66
city: Sagamihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 45
city: Saga
country: Japan
facility: Boehringer Ingelheim Investigational Site 108
city: Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 22
city: Sakai
country: Japan
facility: Boehringer Ingelheim Investigational Site 79
city: Sanjo
country: Japan
facility: Boehringer Ingelheim Investigational Site 52
city: Sanyoonoda
country: Japan
facility: Boehringer Ingelheim Investigational Site 90
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 5
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 6
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 7
city: Sasebo
country: Japan
facility: Boehringer Ingelheim Investigational Site 110
city: Sendai
country: Japan
facility: Boehringer Ingelheim Investigational Site 10
city: Shimonoseki
country: Japan
facility: Boehringer Ingelheim Investigational Site 91
city: Shimotsuke
country: Japan
facility: Boehringer Ingelheim Investigational Site 18
city: Shingu
country: Japan
facility: Boehringer Ingelheim Investigational Site 85
city: Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 57
city: Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 58
city: Suita
country: Japan
facility: Boehringer Ingelheim Investigational Site 73
city: Tagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 101
city: Takamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 96
city: Takatsuki
country: Japan
facility: Boehringer Ingelheim Investigational Site 74
city: Takatsuki
country: Japan
facility: Boehringer Ingelheim Investigational Site 75
city: Togitsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 109
city: Tokushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 92
city: Tokyo Adachi-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 30
city: Tokyo Arakawa-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 31
city: Tokyo Bunkyo-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 40
city: Tokyo Bunkyo-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 41
city: Tokyo Bunkyo-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 42
city: Tokyo Chiyoda-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 38
city: Tokyo Itabashi-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 32
city: Tokyo Itabashi-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 33
city: Tokyo Meguro-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 43
city: Tokyo Nakano-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 39
city: Tokyo Ota-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 34
city: Tokyo Ota-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 35
city: Tokyo Shinjuku-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 36
city: Tokyo Shinjuku-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 37
city: Tokyo Toshima-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 44
city: Tomiai
country: Japan
facility: Boehringer Ingelheim Investigational Site 113
city: Toride
country: Japan
facility: Boehringer Ingelheim Investigational Site 14
city: Tsukuba
country: Japan
facility: Boehringer Ingelheim Investigational Site 16
city: Tsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 65
city: Uchinada
country: Japan
facility: Boehringer Ingelheim Investigational Site 53
city: Urayasu
country: Japan
facility: Boehringer Ingelheim Investigational Site 29
city: Wakayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 84
city: Yamaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 89
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 47
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 48
city: Yoshinogawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 94
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: