Clinical trial NCT01525641: Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
Official title: Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 615
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Adverse Drug Reactions
timeFrame: From baseline up to week 52
Secondary outcomes:
measure: Clinical Global Impression of Effect
timeFrame: Week 52
measure: Change From Baseline in Total Score of the UPDRS Part III to Last Observation
timeFrame: Baseline and week 52
measure: Change From Baseline in the Modified Hoehn & Yahr to Last Observation
timeFrame: Baseline and week 52
measure: Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
timeFrame: Week 52
measure: Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA
timeFrame: Week 52
Other outcomes:
Locations:
city: Abiko,Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 28
city: Akashi,Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 86
city: Akita,Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 13
city: Aomori,Aomori
country: Japan
facility: Boehringer Ingelheim Investigational Site 9
city: Asahikawa,Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Bunkyo,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 36
city: Chuo,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 35
city: Chuo,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 40
city: Chuo,Yamanashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 54
city: Date,Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 6
city: Edogawa,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 34
city: Fuchu,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 32
city: Fujioka,Gunma
country: Japan
facility: Boehringer Ingelheim Investigational Site 22
city: Fujisawa,Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 46
city: Fujisawa,Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 48
city: Fukaya,Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 24
city: Fukui,Fukui
country: Japan
facility: Boehringer Ingelheim Investigational Site 53
city: Fukuoka,Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 105
city: Fukuoka,Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 106
city: Fukuoka,Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 109
city: Fukushima,Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 16
city: Gifu,Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 60
city: Hadano,Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 44
city: Hamamatsu,Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 62
city: Hiroshima,Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 96
city: Hiroshima,Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 97
city: Ibaraki,Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 78
city: Ichihara,Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 29
city: Ichinomiya,Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 68
city: Iida,Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 57
city: Iiduka,Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 108
city: Ikoma,Nara
country: Japan
facility: Boehringer Ingelheim Investigational Site 88
city: Imabari,Ehime
country: Japan
facility: Boehringer Ingelheim Investigational Site 103
city: Iwaki,Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 17
city: Iwamizawa,Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Kirishima,Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 117
city: Kitakyushu,Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 111
city: Kitami,Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 5
city: Kofu,Yamanashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 55
city: Konan,Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 70
city: Koshigaya,Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 27
city: Kumamoto,Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 114
city: Kurume,Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 107
city: Kyoto,Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 77
city: Maebashi,Gunma
country: Japan
facility: Boehringer Ingelheim Investigational Site 23
city: Minato,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 42
city: Miyakonojo,Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 116
city: Miyoshi,Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 66
city: Morioka,Iwate
country: Japan
facility: Boehringer Ingelheim Investigational Site 10
city: Moriyama,Shiga
country: Japan
facility: Boehringer Ingelheim Investigational Site 74
city: Muroran,Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Nagano,Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 56
city: Nagareyama,Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 30
city: Nagasaki,Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 113
city: Nagoya,Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 65
city: Nagoya,Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 67
city: Nanao,Ishikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 52
city: Nangoku,Kouchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 104
city: Niigata,Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 50
city: Nishinomiya,Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 85
city: Obu,Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 72
city: Ogaki,Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 61
city: Ohta,Shimane
country: Japan
facility: Boehringer Ingelheim Investigational Site 92
city: Oita,Oita
country: Japan
facility: Boehringer Ingelheim Investigational Site 115
city: Okayama,Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 93
city: Okayama,Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 95
city: Okinawa,Okinawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 118
city: Onojo,Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 110
city: Osaka,Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 80
city: Osaka,Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 81
city: Osaka,Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 82
city: Ota,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 38
city: Otsu,Shiga
country: Japan
facility: Boehringer Ingelheim Investigational Site 75
city: Otsu,Shiga
country: Japan
facility: Boehringer Ingelheim Investigational Site 76
city: Ryugasaki,Ibaragi
country: Japan
facility: Boehringer Ingelheim Investigational Site 18
city: Sagamihara,Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 43
city: Sagamihara,Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 47
city: Saitama,Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 25
city: Saitama,Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 26
city: Sakai,Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 79
city: Sakai,Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 83
city: Sakaide,Kagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 102
city: Saku,Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 58
city: Sakura,Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 31
city: Sanyo-Onoda
country: Japan
facility: Boehringer Ingelheim Investigational Site 98
city: Sapporo,Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Sapporo,Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 7
city: Sapporo,Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 8
city: Sekigahara,Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 59
city: Sendai,Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 11
city: Sendai,Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 12
city: Setagaya,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 33
city: Seto,Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 69
city: Shimoda,Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 63
city: Shimoda,Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 64
city: Shimonoseki,Yamaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 99
city: Shimotsuke,Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 20
city: Shimotsuke,Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 21
city: Shingu,Wakayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 90
city: Shinjuku,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 37
city: Shinjuku,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 39
city: Shinjuku,Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 41
city: Takaoka,Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 51
city: Tokushima,Tokushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 101
city: Tosu,Saga
country: Japan
facility: Boehringer Ingelheim Investigational Site 112
city: Toyokawa,Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 71
city: Toyonaka,Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 84
city: Toyooka,Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 87
city: Tsu,Mie
country: Japan
facility: Boehringer Ingelheim Investigational Site 73
city: Tsukuba,Ibaragi
country: Japan
facility: Boehringer Ingelheim Investigational Site 19
city: Tsukubo,Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 94
city: Tsuruoka,Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 15
city: Wakayama,Wakayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 89
city: Yazu,Tottori
country: Japan
facility: Boehringer Ingelheim Investigational Site 91
city: Yokohama,Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 45
city: Yokohama,Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 49
city: Yokote,Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 14
city: Yoshinogawa,Tokushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 100
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: