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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525641
• Other study ID #: 248.680
• Status: Completed
• Phase: N/A
• First received: February 1, 2012
• Last updated: July 17, 2015
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Mirapex LA
Pramipexole Hydrochloride Hydrate

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Adverse Drug Reactions	Percentage of subjects with adverse drug reactions	From baseline up to week 52	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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