MedDataX Logo

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

NCT ID: NCT01525641

Last Updated: 2015-08-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

615 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

NCT02248168

Parkinson Disease
COMPLETED

Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

NCT00986414

Parkinson Disease Dyskinesias
COMPLETED PHASE2

A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients

NCT01631812

Parkinson's Disease
COMPLETED PHASE2

Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

NCT00321854

Parkinson Disease
COMPLETED PHASE4

Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

NCT00615914

Parkinson Disease
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient with Parkinson's Disease

Mirapex LA

Intervention Type DRUG

Pramipexole Hydrochloride Hydrate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mirapex LA

Pramipexole Hydrochloride Hydrate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\- None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boehringer Ingelheim Investigational Site 28

Abiko,Chiba, , Japan

Site Status

Boehringer Ingelheim Investigational Site 86

Akashi,Hyogo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 13

Akita,Akita, , Japan

Site Status

Boehringer Ingelheim Investigational Site 9

Aomori,Aomori, , Japan

Site Status

Boehringer Ingelheim Investigational Site 2

Asahikawa,Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site 36

Bunkyo,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 35

Chuo,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 40

Chuo,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 54

Chuo,Yamanashi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 6

Date,Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site 34

Edogawa,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 32

Fuchu,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 22

Fujioka,Gunma, , Japan

Site Status

Boehringer Ingelheim Investigational Site 46

Fujisawa,Kanagawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 48

Fujisawa,Kanagawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 24

Fukaya,Saitama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 53

Fukui,Fukui, , Japan

Site Status

Boehringer Ingelheim Investigational Site 105

Fukuoka,Fukuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 106

Fukuoka,Fukuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 109

Fukuoka,Fukuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 16

Fukushima,Fukushima, , Japan

Site Status

Boehringer Ingelheim Investigational Site 60

Gifu,Gifu, , Japan

Site Status

Boehringer Ingelheim Investigational Site 44

Hadano,Kanagawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 62

Hamamatsu,Shizuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 96

Hiroshima,Hiroshima, , Japan

Site Status

Boehringer Ingelheim Investigational Site 97

Hiroshima,Hiroshima, , Japan

Site Status

Boehringer Ingelheim Investigational Site 78

Ibaraki,Osaka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 29

Ichihara,Chiba, , Japan

Site Status

Boehringer Ingelheim Investigational Site 68

Ichinomiya,Aichi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 57

Iida,Nagano, , Japan

Site Status

Boehringer Ingelheim Investigational Site 108

Iiduka,Fukuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 88

Ikoma,Nara, , Japan

Site Status

Boehringer Ingelheim Investigational Site 103

Imabari,Ehime, , Japan

Site Status

Boehringer Ingelheim Investigational Site 17

Iwaki,Fukushima, , Japan

Site Status

Boehringer Ingelheim Investigational Site 3

Iwamizawa,Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site 117

Kirishima,Kagoshima, , Japan

Site Status

Boehringer Ingelheim Investigational Site 111

Kitakyushu,Fukuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 5

Kitami,Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site 55

Kofu,Yamanashi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 70

Konan,Aichi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 27

Koshigaya,Saitama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 114

Kumamoto,Kumamoto, , Japan

Site Status

Boehringer Ingelheim Investigational Site 107

Kurume,Fukuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 77

Kyoto,Kyoto, , Japan

Site Status

Boehringer Ingelheim Investigational Site 23

Maebashi,Gunma, , Japan

Site Status

Boehringer Ingelheim Investigational Site 42

Minato,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 116

Miyakonojo,Miyazaki, , Japan

Site Status

Boehringer Ingelheim Investigational Site 66

Miyoshi,Aichi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 10

Morioka,Iwate, , Japan

Site Status

Boehringer Ingelheim Investigational Site 74

Moriyama,Shiga, , Japan

Site Status

Boehringer Ingelheim Investigational Site 4

Muroran,Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site 56

Nagano,Nagano, , Japan

Site Status

Boehringer Ingelheim Investigational Site 30

Nagareyama,Chiba, , Japan

Site Status

Boehringer Ingelheim Investigational Site 113

Nagasaki,Nagasaki, , Japan

Site Status

Boehringer Ingelheim Investigational Site 65

Nagoya,Aichi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 67

Nagoya,Aichi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 52

Nanao,Ishikawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 104

Nangoku,Kouchi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 50

Niigata,Niigata, , Japan

Site Status

Boehringer Ingelheim Investigational Site 85

Nishinomiya,Hyogo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 72

Obu,Aichi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 61

Ogaki,Gifu, , Japan

Site Status

Boehringer Ingelheim Investigational Site 92

Ohta,Shimane, , Japan

Site Status

Boehringer Ingelheim Investigational Site 115

Oita,Oita, , Japan

Site Status

Boehringer Ingelheim Investigational Site 93

Okayama,Okayama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 95

Okayama,Okayama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 118

Okinawa,Okinawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 110

Onojo,Fukuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 80

Osaka,Osaka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 81

Osaka,Osaka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 82

Osaka,Osaka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 38

Ota,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 75

Otsu,Shiga, , Japan

Site Status

Boehringer Ingelheim Investigational Site 76

Otsu,Shiga, , Japan

Site Status

Boehringer Ingelheim Investigational Site 18

Ryugasaki,Ibaragi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 43

Sagamihara,Kanagawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 47

Sagamihara,Kanagawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 25

Saitama,Saitama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 26

Saitama,Saitama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 79

Sakai,Osaka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 83

Sakai,Osaka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 102

Sakaide,Kagawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 58

Saku,Nagano, , Japan

Site Status

Boehringer Ingelheim Investigational Site 31

Sakura,Chiba, , Japan

Site Status

Boehringer Ingelheim Investigational Site 98

Sanyōonoda, , Japan

Site Status

Boehringer Ingelheim Investigational Site 1

Sapporo,Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site 7

Sapporo,Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site 8

Sapporo,Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site 59

Sekigahara,Gifu, , Japan

Site Status

Boehringer Ingelheim Investigational Site 11

Sendai,Miyagi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 12

Sendai,Miyagi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 33

Setagaya,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 69

Seto,Aichi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 63

Shimoda,Shizuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 64

Shimoda,Shizuoka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 99

Shimonoseki,Yamaguchi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 20

Shimotsuke,Tochigi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 21

Shimotsuke,Tochigi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 90

Shingu,Wakayama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 37

Shinjuku,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 39

Shinjuku,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 41

Shinjuku,Tokyo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 51

Takaoka,Toyama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 101

Tokushima,Tokushima, , Japan

Site Status

Boehringer Ingelheim Investigational Site 112

Tosu,Saga, , Japan

Site Status

Boehringer Ingelheim Investigational Site 71

Toyokawa,Aichi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 84

Toyonaka,Osaka, , Japan

Site Status

Boehringer Ingelheim Investigational Site 87

Toyooka,Hyogo, , Japan

Site Status

Boehringer Ingelheim Investigational Site 73

Tsu,Mie, , Japan

Site Status

Boehringer Ingelheim Investigational Site 19

Tsukuba,Ibaragi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 94

Tsukubo,Okayama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 15

Tsuruoka,Yamagata, , Japan

Site Status

Boehringer Ingelheim Investigational Site 89

Wakayama,Wakayama, , Japan

Site Status

Boehringer Ingelheim Investigational Site 91

Yazu,Tottori, , Japan

Site Status

Boehringer Ingelheim Investigational Site 45

Yokohama,Kanagawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 49

Yokohama,Kanagawa, , Japan

Site Status

Boehringer Ingelheim Investigational Site 14

Yokote,Akita, , Japan

Site Status

Boehringer Ingelheim Investigational Site 100

Yoshinogawa,Tokushima, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

248.680

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease
NCT01603069 COMPLETED PHASE2
A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients
NCT00537485 COMPLETED PHASE2/PHASE3
Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)
NCT01515774 UNKNOWN PHASE4
Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
NCT01491529 COMPLETED PHASE2
A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease
NCT04658186 COMPLETED PHASE2
Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia
NCT05297201 COMPLETED PHASE2
A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
NCT01628848 COMPLETED PHASE2
A Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease
NCT06175767 NOT_YET_RECRUITING PHASE2
A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)
NCT04875962 COMPLETED PHASE1
A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients
NCT01634243 COMPLETED PHASE2
A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants
NCT02337764 COMPLETED PHASE3
A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients
NCT01628965 COMPLETED PHASE2/PHASE3
Impact of Pharmaceutical Care on Drug-related Problems in Patients With Parkinson's Disease
NCT05410210 COMPLETED NA
Is Long-term Use of Amantadine Effective in PD?
NCT04260581 UNKNOWN NA
A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.
NCT01929317 TERMINATED PHASE3
A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
NCT02337751 COMPLETED PHASE3
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
NCT02565628 COMPLETED PHASE1
Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients
NCT00203164 COMPLETED PHASE3
An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor
NCT02668146 UNKNOWN PHASE2
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline
NCT01879748 COMPLETED PHASE1
A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients
NCT01628926 COMPLETED PHASE3
Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
NCT01100073 COMPLETED
A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)
NCT00148486 COMPLETED PHASE2
Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
NCT01385592 COMPLETED PHASE2
A Study of KW-6356 in Subjects With Early Parkinson's Disease
NCT02939391 COMPLETED PHASE2