Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Mirapex LA

• Study Type: Observational
• Enrollment (Actual): 615

Contacts and Locations

Study Locations

• Japan
  • Abiko,Chiba, Japan
    • Boehringer Ingelheim Investigational Site 28
  • Akashi,Hyogo, Japan
    • Boehringer Ingelheim Investigational Site 86
  • Akita,Akita, Japan
    • Boehringer Ingelheim Investigational Site 13
  • Aomori,Aomori, Japan
    • Boehringer Ingelheim Investigational Site 9
  • Asahikawa,Hokkaido, Japan
    • Boehringer Ingelheim Investigational Site 2
  • Bunkyo,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 36
  • Chuo,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 35
  • Chuo,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 40
  • Chuo,Yamanashi, Japan
    • Boehringer Ingelheim Investigational Site 54
  • Date,Hokkaido, Japan
    • Boehringer Ingelheim Investigational Site 6
  • Edogawa,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 34
  • Fuchu,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 32
  • Fujioka,Gunma, Japan
    • Boehringer Ingelheim Investigational Site 22
  • Fujisawa,Kanagawa, Japan
    • Boehringer Ingelheim Investigational Site 46
  • Fujisawa,Kanagawa, Japan
    • Boehringer Ingelheim Investigational Site 48
  • Fukaya,Saitama, Japan
    • Boehringer Ingelheim Investigational Site 24
  • Fukui,Fukui, Japan
    • Boehringer Ingelheim Investigational Site 53
  • Fukuoka,Fukuoka, Japan
    • Boehringer Ingelheim Investigational Site 105
  • Fukuoka,Fukuoka, Japan
    • Boehringer Ingelheim Investigational Site 106
  • Fukuoka,Fukuoka, Japan
    • Boehringer Ingelheim Investigational Site 109
  • Fukushima,Fukushima, Japan
    • Boehringer Ingelheim Investigational Site 16
  • Gifu,Gifu, Japan
    • Boehringer Ingelheim Investigational Site 60
  • Hadano,Kanagawa, Japan
    • Boehringer Ingelheim Investigational Site 44
  • Hamamatsu,Shizuoka, Japan
    • Boehringer Ingelheim Investigational Site 62
  • Hiroshima,Hiroshima, Japan
    • Boehringer Ingelheim Investigational Site 96
  • Hiroshima,Hiroshima, Japan
    • Boehringer Ingelheim Investigational Site 97
  • Ibaraki,Osaka, Japan
    • Boehringer Ingelheim Investigational Site 78
  • Ichihara,Chiba, Japan
    • Boehringer Ingelheim Investigational Site 29
  • Ichinomiya,Aichi, Japan
    • Boehringer Ingelheim Investigational Site 68
  • Iida,Nagano, Japan
    • Boehringer Ingelheim Investigational Site 57
  • Iiduka,Fukuoka, Japan
    • Boehringer Ingelheim Investigational Site 108
  • Ikoma,Nara, Japan
    • Boehringer Ingelheim Investigational Site 88
  • Imabari,Ehime, Japan
    • Boehringer Ingelheim Investigational Site 103
  • Iwaki,Fukushima, Japan
    • Boehringer Ingelheim Investigational Site 17
  • Iwamizawa,Hokkaido, Japan
    • Boehringer Ingelheim Investigational Site 3
  • Kirishima,Kagoshima, Japan
    • Boehringer Ingelheim Investigational Site 117
  • Kitakyushu,Fukuoka, Japan
    • Boehringer Ingelheim Investigational Site 111
  • Kitami,Hokkaido, Japan
    • Boehringer Ingelheim Investigational Site 5
  • Kofu,Yamanashi, Japan
    • Boehringer Ingelheim Investigational Site 55
  • Konan,Aichi, Japan
    • Boehringer Ingelheim Investigational Site 70
  • Koshigaya,Saitama, Japan
    • Boehringer Ingelheim Investigational Site 27
  • Kumamoto,Kumamoto, Japan
    • Boehringer Ingelheim Investigational Site 114
  • Kurume,Fukuoka, Japan
    • Boehringer Ingelheim Investigational Site 107
  • Kyoto,Kyoto, Japan
    • Boehringer Ingelheim Investigational Site 77
  • Maebashi,Gunma, Japan
    • Boehringer Ingelheim Investigational Site 23
  • Minato,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 42
  • Miyakonojo,Miyazaki, Japan
    • Boehringer Ingelheim Investigational Site 116
  • Miyoshi,Aichi, Japan
    • Boehringer Ingelheim Investigational Site 66
  • Morioka,Iwate, Japan
    • Boehringer Ingelheim Investigational Site 10
  • Moriyama,Shiga, Japan
    • Boehringer Ingelheim Investigational Site 74
  • Muroran,Hokkaido, Japan
    • Boehringer Ingelheim Investigational Site 4
  • Nagano,Nagano, Japan
    • Boehringer Ingelheim Investigational Site 56
  • Nagareyama,Chiba, Japan
    • Boehringer Ingelheim Investigational Site 30
  • Nagasaki,Nagasaki, Japan
    • Boehringer Ingelheim Investigational Site 113
  • Nagoya,Aichi, Japan
    • Boehringer Ingelheim Investigational Site 65
  • Nagoya,Aichi, Japan
    • Boehringer Ingelheim Investigational Site 67
  • Nanao,Ishikawa, Japan
    • Boehringer Ingelheim Investigational Site 52
  • Nangoku,Kouchi, Japan
    • Boehringer Ingelheim Investigational Site 104
  • Niigata,Niigata, Japan
    • Boehringer Ingelheim Investigational Site 50
  • Nishinomiya,Hyogo, Japan
    • Boehringer Ingelheim Investigational Site 85
  • Obu,Aichi, Japan
    • Boehringer Ingelheim Investigational Site 72
  • Ogaki,Gifu, Japan
    • Boehringer Ingelheim Investigational Site 61
  • Ohta,Shimane, Japan
    • Boehringer Ingelheim Investigational Site 92
  • Oita,Oita, Japan
    • Boehringer Ingelheim Investigational Site 115
  • Okayama,Okayama, Japan
    • Boehringer Ingelheim Investigational Site 93
  • Okayama,Okayama, Japan
    • Boehringer Ingelheim Investigational Site 95
  • Okinawa,Okinawa, Japan
    • Boehringer Ingelheim Investigational Site 118
  • Onojo,Fukuoka, Japan
    • Boehringer Ingelheim Investigational Site 110
  • Osaka,Osaka, Japan
    • Boehringer Ingelheim Investigational Site 80
  • Osaka,Osaka, Japan
    • Boehringer Ingelheim Investigational Site 81
  • Osaka,Osaka, Japan
    • Boehringer Ingelheim Investigational Site 82
  • Ota,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 38
  • Otsu,Shiga, Japan
    • Boehringer Ingelheim Investigational Site 75
  • Otsu,Shiga, Japan
    • Boehringer Ingelheim Investigational Site 76
  • Ryugasaki,Ibaragi, Japan
    • Boehringer Ingelheim Investigational Site 18
  • Sagamihara,Kanagawa, Japan
    • Boehringer Ingelheim Investigational Site 43
  • Sagamihara,Kanagawa, Japan
    • Boehringer Ingelheim Investigational Site 47
  • Saitama,Saitama, Japan
    • Boehringer Ingelheim Investigational Site 25
  • Saitama,Saitama, Japan
    • Boehringer Ingelheim Investigational Site 26
  • Sakai,Osaka, Japan
    • Boehringer Ingelheim Investigational Site 79
  • Sakai,Osaka, Japan
    • Boehringer Ingelheim Investigational Site 83
  • Sakaide,Kagawa, Japan
    • Boehringer Ingelheim Investigational Site 102
  • Saku,Nagano, Japan
    • Boehringer Ingelheim Investigational Site 58
  • Sakura,Chiba, Japan
    • Boehringer Ingelheim Investigational Site 31
  • Sanyo-Onoda, Japan
    • Boehringer Ingelheim Investigational Site 98
  • Sapporo,Hokkaido, Japan
    • Boehringer Ingelheim Investigational Site 1
  • Sapporo,Hokkaido, Japan
    • Boehringer Ingelheim Investigational Site 7
  • Sapporo,Hokkaido, Japan
    • Boehringer Ingelheim Investigational Site 8
  • Sekigahara,Gifu, Japan
    • Boehringer Ingelheim Investigational Site 59
  • Sendai,Miyagi, Japan
    • Boehringer Ingelheim Investigational Site 11
  • Sendai,Miyagi, Japan
    • Boehringer Ingelheim Investigational Site 12
  • Setagaya,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 33
  • Seto,Aichi, Japan
    • Boehringer Ingelheim Investigational Site 69
  • Shimoda,Shizuoka, Japan
    • Boehringer Ingelheim Investigational Site 63
  • Shimoda,Shizuoka, Japan
    • Boehringer Ingelheim Investigational Site 64
  • Shimonoseki,Yamaguchi, Japan
    • Boehringer Ingelheim Investigational Site 99
  • Shimotsuke,Tochigi, Japan
    • Boehringer Ingelheim Investigational Site 20
  • Shimotsuke,Tochigi, Japan
    • Boehringer Ingelheim Investigational Site 21
  • Shingu,Wakayama, Japan
    • Boehringer Ingelheim Investigational Site 90
  • Shinjuku,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 37
  • Shinjuku,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 39
  • Shinjuku,Tokyo, Japan
    • Boehringer Ingelheim Investigational Site 41
  • Takaoka,Toyama, Japan
    • Boehringer Ingelheim Investigational Site 51
  • Tokushima,Tokushima, Japan
    • Boehringer Ingelheim Investigational Site 101
  • Tosu,Saga, Japan
    • Boehringer Ingelheim Investigational Site 112
  • Toyokawa,Aichi, Japan
    • Boehringer Ingelheim Investigational Site 71
  • Toyonaka,Osaka, Japan
    • Boehringer Ingelheim Investigational Site 84
  • Toyooka,Hyogo, Japan
    • Boehringer Ingelheim Investigational Site 87
  • Tsu,Mie, Japan
    • Boehringer Ingelheim Investigational Site 73
  • Tsukuba,Ibaragi, Japan
    • Boehringer Ingelheim Investigational Site 19
  • Tsukubo,Okayama, Japan
    • Boehringer Ingelheim Investigational Site 94
  • Tsuruoka,Yamagata, Japan
    • Boehringer Ingelheim Investigational Site 15
  • Wakayama,Wakayama, Japan
    • Boehringer Ingelheim Investigational Site 89
  • Yazu,Tottori, Japan
    • Boehringer Ingelheim Investigational Site 91
  • Yokohama,Kanagawa, Japan
    • Boehringer Ingelheim Investigational Site 45
  • Yokohama,Kanagawa, Japan
    • Boehringer Ingelheim Investigational Site 49
  • Yokote,Akita, Japan
    • Boehringer Ingelheim Investigational Site 14
  • Yoshinogawa,Tokushima, Japan
    • Boehringer Ingelheim Investigational Site 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

600

Description

Inclusion criteria:

- Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.

Exclusion criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with Parkinson's Disease	Drug: Mirapex LA; Pramipexole Hydrochloride Hydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Adverse Drug Reactions	Percentage of subjects with adverse drug reactions	From baseline up to week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression of Effect	Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.	Week 52
Change From Baseline in Total Score of the UPDRS Part III to Last Observation	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.	Baseline and week 52
Change From Baseline in the Modified Hoehn & Yahr to Last Observation	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.	Baseline and week 52
Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA	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".	Week 52
Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA	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.	Week 52

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Estimate): August 14, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Dopamine Agonists; Dopamine Agents; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Pramipexole
• Other Study ID Numbers: 248.680