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

NCT01525641 | Completed Results

• 1 other identifier: 248.680
• Study Type: observational
• Target: 615
• Locations: 1 country
• Sites: 118

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Adverse Drug Reactions

  Percentage of subjects with adverse drug reactions

  From baseline up to week 52

Secondary Outcomes (5)

• Clinical Global Impression of Effect

  Week 52

• Change From Baseline in Total Score of the UPDRS Part III to Last Observation

  Baseline and week 52

• Change From Baseline in the Modified Hoehn & Yahr to Last Observation

  Baseline and week 52

• Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA

  Week 52

• Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA

  Week 52

Study Arms (1)

Patient with Parkinson's Disease

Drug: Mirapex LA

Interventions

Mirapex LA DRUG

Pramipexole Hydrochloride Hydrate

Patient with Parkinson's Disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

600

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (118)

Boehringer Ingelheim Investigational Site 28

Abiko,Chiba, Japan

Location

Boehringer Ingelheim Investigational Site 86

Akashi,Hyogo, Japan

Location

Boehringer Ingelheim Investigational Site 13

Akita,Akita, Japan

Location

Boehringer Ingelheim Investigational Site 9

Aomori,Aomori, Japan

Location

Boehringer Ingelheim Investigational Site 2

Asahikawa,Hokkaido, Japan

Location

Boehringer Ingelheim Investigational Site 36

Bunkyo,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 35

Chuo,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 40

Chuo,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 54

Chuo,Yamanashi, Japan

Location

Boehringer Ingelheim Investigational Site 6

Date,Hokkaido, Japan

Location

Boehringer Ingelheim Investigational Site 34

Edogawa,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 32

Fuchu,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 22

Fujioka,Gunma, Japan

Location

Boehringer Ingelheim Investigational Site 46

Fujisawa,Kanagawa, Japan

Location

Boehringer Ingelheim Investigational Site 48

Fujisawa,Kanagawa, Japan

Location

Boehringer Ingelheim Investigational Site 24

Fukaya,Saitama, Japan

Location

Boehringer Ingelheim Investigational Site 53

Fukui,Fukui, Japan

Location

Boehringer Ingelheim Investigational Site 105

Fukuoka,Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 106

Fukuoka,Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 109

Fukuoka,Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 16

Fukushima,Fukushima, Japan

Location

Boehringer Ingelheim Investigational Site 60

Gifu,Gifu, Japan

Location

Boehringer Ingelheim Investigational Site 44

Hadano,Kanagawa, Japan

Location

Boehringer Ingelheim Investigational Site 62

Hamamatsu,Shizuoka, Japan

Location

Boehringer Ingelheim Investigational Site 96

Hiroshima,Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site 97

Hiroshima,Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site 78

Ibaraki,Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 29

Ichihara,Chiba, Japan

Location

Boehringer Ingelheim Investigational Site 68

Ichinomiya,Aichi, Japan

Location

Boehringer Ingelheim Investigational Site 57

Iida,Nagano, Japan

Location

Boehringer Ingelheim Investigational Site 108

Iiduka,Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 88

Ikoma,Nara, Japan

Location

Boehringer Ingelheim Investigational Site 103

Imabari,Ehime, Japan

Location

Boehringer Ingelheim Investigational Site 17

Iwaki,Fukushima, Japan

Location

Boehringer Ingelheim Investigational Site 3

Iwamizawa,Hokkaido, Japan

Location

Boehringer Ingelheim Investigational Site 117

Kirishima,Kagoshima, Japan

Location

Boehringer Ingelheim Investigational Site 111

Kitakyushu,Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 5

Kitami,Hokkaido, Japan

Location

Boehringer Ingelheim Investigational Site 55

Kofu,Yamanashi, Japan

Location

Boehringer Ingelheim Investigational Site 70

Konan,Aichi, Japan

Location

Boehringer Ingelheim Investigational Site 27

Koshigaya,Saitama, Japan

Location

Boehringer Ingelheim Investigational Site 114

Kumamoto,Kumamoto, Japan

Location

Boehringer Ingelheim Investigational Site 107

Kurume,Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 77

Kyoto,Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 23

Maebashi,Gunma, Japan

Location

Boehringer Ingelheim Investigational Site 42

Minato,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 116

Miyakonojo,Miyazaki, Japan

Location

Boehringer Ingelheim Investigational Site 66

Miyoshi,Aichi, Japan

Location

Boehringer Ingelheim Investigational Site 10

Morioka,Iwate, Japan

Location

Boehringer Ingelheim Investigational Site 74

Moriyama,Shiga, Japan

Location

Boehringer Ingelheim Investigational Site 4

Muroran,Hokkaido, Japan

Location

Boehringer Ingelheim Investigational Site 56

Nagano,Nagano, Japan

Location

Boehringer Ingelheim Investigational Site 30

Nagareyama,Chiba, Japan

Location

Boehringer Ingelheim Investigational Site 113

Nagasaki,Nagasaki, Japan

Location

Boehringer Ingelheim Investigational Site 65

Nagoya,Aichi, Japan

Location

Boehringer Ingelheim Investigational Site 67

Nagoya,Aichi, Japan

Location

Boehringer Ingelheim Investigational Site 52

Nanao,Ishikawa, Japan

Location

Boehringer Ingelheim Investigational Site 104

Nangoku,Kouchi, Japan

Location

Boehringer Ingelheim Investigational Site 50

Niigata,Niigata, Japan

Location

Boehringer Ingelheim Investigational Site 85

Nishinomiya,Hyogo, Japan

Location

Boehringer Ingelheim Investigational Site 72

Obu,Aichi, Japan

Location

Boehringer Ingelheim Investigational Site 61

Ogaki,Gifu, Japan

Location

Boehringer Ingelheim Investigational Site 92

Ohta,Shimane, Japan

Location

Boehringer Ingelheim Investigational Site 115

Oita,Oita, Japan

Location

Boehringer Ingelheim Investigational Site 93

Okayama,Okayama, Japan

Location

Boehringer Ingelheim Investigational Site 95

Okayama,Okayama, Japan

Location

Boehringer Ingelheim Investigational Site 118

Okinawa,Okinawa, Japan

Location

Boehringer Ingelheim Investigational Site 110

Onojo,Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 80

Osaka,Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 81

Osaka,Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 82

Osaka,Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 38

Ota,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 75

Otsu,Shiga, Japan

Location

Boehringer Ingelheim Investigational Site 76

Otsu,Shiga, Japan

Location

Boehringer Ingelheim Investigational Site 18

Ryugasaki,Ibaragi, Japan

Location

Boehringer Ingelheim Investigational Site 43

Sagamihara,Kanagawa, Japan

Location

Boehringer Ingelheim Investigational Site 47

Sagamihara,Kanagawa, Japan

Location

Boehringer Ingelheim Investigational Site 25

Saitama,Saitama, Japan

Location

Boehringer Ingelheim Investigational Site 26

Saitama,Saitama, Japan

Location

Boehringer Ingelheim Investigational Site 79

Sakai,Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 83

Sakai,Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 102

Sakaide,Kagawa, Japan

Location

Boehringer Ingelheim Investigational Site 58

Saku,Nagano, Japan

Location

Boehringer Ingelheim Investigational Site 31

Sakura,Chiba, Japan

Location

Boehringer Ingelheim Investigational Site 98

Sanyōonoda, Japan

Location

Boehringer Ingelheim Investigational Site 1

Sapporo,Hokkaido, Japan

Location

Boehringer Ingelheim Investigational Site 7

Sapporo,Hokkaido, Japan

Location

Boehringer Ingelheim Investigational Site 8

Sapporo,Hokkaido, Japan

Location

Boehringer Ingelheim Investigational Site 59

Sekigahara,Gifu, Japan

Location

Boehringer Ingelheim Investigational Site 11

Sendai,Miyagi, Japan

Location

Boehringer Ingelheim Investigational Site 12

Sendai,Miyagi, Japan

Location

Boehringer Ingelheim Investigational Site 33

Setagaya,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 69

Seto,Aichi, Japan

Location

Boehringer Ingelheim Investigational Site 63

Shimoda,Shizuoka, Japan

Location

Boehringer Ingelheim Investigational Site 64

Shimoda,Shizuoka, Japan

Location

Boehringer Ingelheim Investigational Site 99

Shimonoseki,Yamaguchi, Japan

Location

Boehringer Ingelheim Investigational Site 20

Shimotsuke,Tochigi, Japan

Location

Boehringer Ingelheim Investigational Site 21

Shimotsuke,Tochigi, Japan

Location

Boehringer Ingelheim Investigational Site 90

Shingu,Wakayama, Japan

Location

Boehringer Ingelheim Investigational Site 37

Shinjuku,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 39

Shinjuku,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 41

Shinjuku,Tokyo, Japan

Location

Boehringer Ingelheim Investigational Site 51

Takaoka,Toyama, Japan

Location

Boehringer Ingelheim Investigational Site 101

Tokushima,Tokushima, Japan

Location

Boehringer Ingelheim Investigational Site 112

Tosu,Saga, Japan

Location

Boehringer Ingelheim Investigational Site 71

Toyokawa,Aichi, Japan

Location

Boehringer Ingelheim Investigational Site 84

Toyonaka,Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 87

Toyooka,Hyogo, Japan

Location

Boehringer Ingelheim Investigational Site 73

Tsu,Mie, Japan

Location

Boehringer Ingelheim Investigational Site 19

Tsukuba,Ibaragi, Japan

Location

Boehringer Ingelheim Investigational Site 94

Tsukubo,Okayama, Japan

Location

Boehringer Ingelheim Investigational Site 15

Tsuruoka,Yamagata, Japan

Location

Boehringer Ingelheim Investigational Site 89

Wakayama,Wakayama, Japan

Location

Boehringer Ingelheim Investigational Site 91

Yazu,Tottori, Japan

Location

Boehringer Ingelheim Investigational Site 45

Yokohama,Kanagawa, Japan

Location

Boehringer Ingelheim Investigational Site 49

Yokohama,Kanagawa, Japan

Location

Boehringer Ingelheim Investigational Site 14

Yokote,Akita, Japan

Location

Boehringer Ingelheim Investigational Site 100

Yoshinogawa,Tokushima, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 14, 2015
• Results First Posted: August 14, 2015

Record last verified: 2015-07

Locations

JP (118)