Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
- Registration Number
- NCT01525641
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 615
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with Parkinson's Disease Mirapex LA -
- Primary Outcome Measures
Name Time Method Percentage of Adverse Drug Reactions From baseline up to week 52 Percentage of subjects with adverse drug reactions
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Modified Hoehn & Yahr to Last Observation Baseline and week 52 Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.
Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA Week 52 Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - "on" - to a sudden inability to move - "off".
Clinical Global Impression of Effect Week 52 Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.
Change From Baseline in Total Score of the UPDRS Part III to Last Observation Baseline and week 52 Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score.
UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status.
The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.
The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia.Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA Week 52 Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.
Trial Locations
- Locations (118)
Boehringer Ingelheim Investigational Site 4
🇯🇵Muroran,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 52
🇯🇵Nanao,Ishikawa, Japan
Boehringer Ingelheim Investigational Site 40
🇯🇵Chuo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 109
🇯🇵Fukuoka,Fukuoka, Japan
Boehringer Ingelheim Investigational Site 28
🇯🇵Abiko,Chiba, Japan
Boehringer Ingelheim Investigational Site 96
🇯🇵Hiroshima,Hiroshima, Japan
Boehringer Ingelheim Investigational Site 114
🇯🇵Kumamoto,Kumamoto, Japan
Boehringer Ingelheim Investigational Site 30
🇯🇵Nagareyama,Chiba, Japan
Boehringer Ingelheim Investigational Site 67
🇯🇵Nagoya,Aichi, Japan
Boehringer Ingelheim Investigational Site 80
🇯🇵Osaka,Osaka, Japan
Boehringer Ingelheim Investigational Site 84
🇯🇵Toyonaka,Osaka, Japan
Boehringer Ingelheim Investigational Site 22
🇯🇵Fujioka,Gunma, Japan
Boehringer Ingelheim Investigational Site 48
🇯🇵Fujisawa,Kanagawa, Japan
Boehringer Ingelheim Investigational Site 16
🇯🇵Fukushima,Fukushima, Japan
Boehringer Ingelheim Investigational Site 44
🇯🇵Hadano,Kanagawa, Japan
Boehringer Ingelheim Investigational Site 62
🇯🇵Hamamatsu,Shizuoka, Japan
Boehringer Ingelheim Investigational Site 77
🇯🇵Kyoto,Kyoto, Japan
Boehringer Ingelheim Investigational Site 74
🇯🇵Moriyama,Shiga, Japan
Boehringer Ingelheim Investigational Site 115
🇯🇵Oita,Oita, Japan
Boehringer Ingelheim Investigational Site 18
🇯🇵Ryugasaki,Ibaragi, Japan
Boehringer Ingelheim Investigational Site 26
🇯🇵Saitama,Saitama, Japan
Boehringer Ingelheim Investigational Site 102
🇯🇵Sakaide,Kagawa, Japan
Boehringer Ingelheim Investigational Site 8
🇯🇵Sapporo,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 69
🇯🇵Seto,Aichi, Japan
Boehringer Ingelheim Investigational Site 53
🇯🇵Fukui,Fukui, Japan
Boehringer Ingelheim Investigational Site 60
🇯🇵Gifu,Gifu, Japan
Boehringer Ingelheim Investigational Site 17
🇯🇵Iwaki,Fukushima, Japan
Boehringer Ingelheim Investigational Site 107
🇯🇵Kurume,Fukuoka, Japan
Boehringer Ingelheim Investigational Site 23
🇯🇵Maebashi,Gunma, Japan
Boehringer Ingelheim Investigational Site 85
🇯🇵Nishinomiya,Hyogo, Japan
Boehringer Ingelheim Investigational Site 61
🇯🇵Ogaki,Gifu, Japan
Boehringer Ingelheim Investigational Site 93
🇯🇵Okayama,Okayama, Japan
Boehringer Ingelheim Investigational Site 95
🇯🇵Okayama,Okayama, Japan
Boehringer Ingelheim Investigational Site 11
🇯🇵Sendai,Miyagi, Japan
Boehringer Ingelheim Investigational Site 33
🇯🇵Setagaya,Tokyo, Japan
Boehringer Ingelheim Investigational Site 99
🇯🇵Shimonoseki,Yamaguchi, Japan
Boehringer Ingelheim Investigational Site 118
🇯🇵Okinawa,Okinawa, Japan
Boehringer Ingelheim Investigational Site 9
🇯🇵Aomori,Aomori, Japan
Boehringer Ingelheim Investigational Site 36
🇯🇵Bunkyo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 27
🇯🇵Koshigaya,Saitama, Japan
Boehringer Ingelheim Investigational Site 65
🇯🇵Nagoya,Aichi, Japan
Boehringer Ingelheim Investigational Site 50
🇯🇵Niigata,Niigata, Japan
Boehringer Ingelheim Investigational Site 72
🇯🇵Obu,Aichi, Japan
Boehringer Ingelheim Investigational Site 81
🇯🇵Osaka,Osaka, Japan
Boehringer Ingelheim Investigational Site 25
🇯🇵Saitama,Saitama, Japan
Boehringer Ingelheim Investigational Site 51
🇯🇵Takaoka,Toyama, Japan
Boehringer Ingelheim Investigational Site 14
🇯🇵Yokote,Akita, Japan
Boehringer Ingelheim Investigational Site 57
🇯🇵Iida,Nagano, Japan
Boehringer Ingelheim Investigational Site 3
🇯🇵Iwamizawa,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 55
🇯🇵Kofu,Yamanashi, Japan
Boehringer Ingelheim Investigational Site 42
🇯🇵Minato,Tokyo, Japan
Boehringer Ingelheim Investigational Site 116
🇯🇵Miyakonojo,Miyazaki, Japan
Boehringer Ingelheim Investigational Site 10
🇯🇵Morioka,Iwate, Japan
Boehringer Ingelheim Investigational Site 56
🇯🇵Nagano,Nagano, Japan
Boehringer Ingelheim Investigational Site 113
🇯🇵Nagasaki,Nagasaki, Japan
Boehringer Ingelheim Investigational Site 104
🇯🇵Nangoku,Kouchi, Japan
Boehringer Ingelheim Investigational Site 92
🇯🇵Ohta,Shimane, Japan
Boehringer Ingelheim Investigational Site 98
🇯🇵Sanyo-Onoda, Japan
Boehringer Ingelheim Investigational Site 1
🇯🇵Sapporo,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 7
🇯🇵Sapporo,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 12
🇯🇵Sendai,Miyagi, Japan
Boehringer Ingelheim Investigational Site 20
🇯🇵Shimotsuke,Tochigi, Japan
Boehringer Ingelheim Investigational Site 21
🇯🇵Shimotsuke,Tochigi, Japan
Boehringer Ingelheim Investigational Site 39
🇯🇵Shinjuku,Tokyo, Japan
Boehringer Ingelheim Investigational Site 41
🇯🇵Shinjuku,Tokyo, Japan
Boehringer Ingelheim Investigational Site 101
🇯🇵Tokushima,Tokushima, Japan
Boehringer Ingelheim Investigational Site 112
🇯🇵Tosu,Saga, Japan
Boehringer Ingelheim Investigational Site 71
🇯🇵Toyokawa,Aichi, Japan
Boehringer Ingelheim Investigational Site 64
🇯🇵Shimoda,Shizuoka, Japan
Boehringer Ingelheim Investigational Site 37
🇯🇵Shinjuku,Tokyo, Japan
Boehringer Ingelheim Investigational Site 100
🇯🇵Yoshinogawa,Tokushima, Japan
Boehringer Ingelheim Investigational Site 94
🇯🇵Tsukubo,Okayama, Japan
Boehringer Ingelheim Investigational Site 89
🇯🇵Wakayama,Wakayama, Japan
Boehringer Ingelheim Investigational Site 78
🇯🇵Ibaraki,Osaka, Japan
Boehringer Ingelheim Investigational Site 29
🇯🇵Ichihara,Chiba, Japan
Boehringer Ingelheim Investigational Site 68
🇯🇵Ichinomiya,Aichi, Japan
Boehringer Ingelheim Investigational Site 108
🇯🇵Iiduka,Fukuoka, Japan
Boehringer Ingelheim Investigational Site 88
🇯🇵Ikoma,Nara, Japan
Boehringer Ingelheim Investigational Site 103
🇯🇵Imabari,Ehime, Japan
Boehringer Ingelheim Investigational Site 117
🇯🇵Kirishima,Kagoshima, Japan
Boehringer Ingelheim Investigational Site 111
🇯🇵Kitakyushu,Fukuoka, Japan
Boehringer Ingelheim Investigational Site 70
🇯🇵Konan,Aichi, Japan
Boehringer Ingelheim Investigational Site 110
🇯🇵Onojo,Fukuoka, Japan
Boehringer Ingelheim Investigational Site 38
🇯🇵Ota,Tokyo, Japan
Boehringer Ingelheim Investigational Site 75
🇯🇵Otsu,Shiga, Japan
Boehringer Ingelheim Investigational Site 76
🇯🇵Otsu,Shiga, Japan
Boehringer Ingelheim Investigational Site 43
🇯🇵Sagamihara,Kanagawa, Japan
Boehringer Ingelheim Investigational Site 47
🇯🇵Sagamihara,Kanagawa, Japan
Boehringer Ingelheim Investigational Site 83
🇯🇵Sakai,Osaka, Japan
Boehringer Ingelheim Investigational Site 58
🇯🇵Saku,Nagano, Japan
Boehringer Ingelheim Investigational Site 59
🇯🇵Sekigahara,Gifu, Japan
Boehringer Ingelheim Investigational Site 91
🇯🇵Yazu,Tottori, Japan
Boehringer Ingelheim Investigational Site 46
🇯🇵Fujisawa,Kanagawa, Japan
Boehringer Ingelheim Investigational Site 105
🇯🇵Fukuoka,Fukuoka, Japan
Boehringer Ingelheim Investigational Site 13
🇯🇵Akita,Akita, Japan
Boehringer Ingelheim Investigational Site 2
🇯🇵Asahikawa,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 35
🇯🇵Chuo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 54
🇯🇵Chuo,Yamanashi, Japan
Boehringer Ingelheim Investigational Site 34
🇯🇵Edogawa,Tokyo, Japan
Boehringer Ingelheim Investigational Site 32
🇯🇵Fuchu,Tokyo, Japan
Boehringer Ingelheim Investigational Site 86
🇯🇵Akashi,Hyogo, Japan
Boehringer Ingelheim Investigational Site 6
🇯🇵Date,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 24
🇯🇵Fukaya,Saitama, Japan
Boehringer Ingelheim Investigational Site 106
🇯🇵Fukuoka,Fukuoka, Japan
Boehringer Ingelheim Investigational Site 97
🇯🇵Hiroshima,Hiroshima, Japan
Boehringer Ingelheim Investigational Site 5
🇯🇵Kitami,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 66
🇯🇵Miyoshi,Aichi, Japan
Boehringer Ingelheim Investigational Site 82
🇯🇵Osaka,Osaka, Japan
Boehringer Ingelheim Investigational Site 79
🇯🇵Sakai,Osaka, Japan
Boehringer Ingelheim Investigational Site 63
🇯🇵Shimoda,Shizuoka, Japan
Boehringer Ingelheim Investigational Site 90
🇯🇵Shingu,Wakayama, Japan
Boehringer Ingelheim Investigational Site 31
🇯🇵Sakura,Chiba, Japan
Boehringer Ingelheim Investigational Site 87
🇯🇵Toyooka,Hyogo, Japan
Boehringer Ingelheim Investigational Site 73
🇯🇵Tsu,Mie, Japan
Boehringer Ingelheim Investigational Site 19
🇯🇵Tsukuba,Ibaragi, Japan
Boehringer Ingelheim Investigational Site 15
🇯🇵Tsuruoka,Yamagata, Japan
Boehringer Ingelheim Investigational Site 45
🇯🇵Yokohama,Kanagawa, Japan
Boehringer Ingelheim Investigational Site 49
🇯🇵Yokohama,Kanagawa, Japan