Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

Parkinson Disease Clinical Trial

Official title:

Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613301
• Other study ID #: 248.549
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: May 28, 2014
• Start date: February 2004

Study information

• Verified date: May 2014
• 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

The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients with Parkinson's disease who do not receive L-Dopa supplementation

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Japan	Boehringer Ingelheim Investigational Site 11	Akita
Japan	Boehringer Ingelheim Investigational Site 95	Anan
Japan	Boehringer Ingelheim Investigational Site 1	Asahikawa
Japan	Boehringer Ingelheim Investigational Site 2	Asahikawa
Japan	Boehringer Ingelheim Investigational Site 26	Chiba
Japan	Boehringer Ingelheim Investigational Site 27	Chiba
Japan	Boehringer Ingelheim Investigational Site 60	Fuji
Japan	Boehringer Ingelheim Investigational Site 49	Fujisawa
Japan	Boehringer Ingelheim Investigational Site 25	Fukaya
Japan	Boehringer Ingelheim Investigational Site 103	Fukuoka
Japan	Boehringer Ingelheim Investigational Site 104	Fukuoka
Japan	Boehringer Ingelheim Investigational Site 105	Fukuoka
Japan	Boehringer Ingelheim Investigational Site 106	Fukuoka
Japan	Boehringer Ingelheim Investigational Site 56	Gifu
Japan	Boehringer Ingelheim Investigational Site 80	Habikino
Japan	Boehringer Ingelheim Investigational Site 3	Hakodate
Japan	Boehringer Ingelheim Investigational Site 59	Hamamatsu
Japan	Boehringer Ingelheim Investigational Site 64	Handa
Japan	Boehringer Ingelheim Investigational Site 82	Himeji
Japan	Boehringer Ingelheim Investigational Site 76	Hirakata
Japan	Boehringer Ingelheim Investigational Site 86	Hiroshima
Japan	Boehringer Ingelheim Investigational Site 87	Hiroshima
Japan	Boehringer Ingelheim Investigational Site 8	Ichinoseki
Japan	Boehringer Ingelheim Investigational Site 118	Kagoshima
Japan	Boehringer Ingelheim Investigational Site 15	Kamisu
Japan	Boehringer Ingelheim Investigational Site 50	Kashiwazaki
Japan	Boehringer Ingelheim Investigational Site 107	Kasuga
Japan	Boehringer Ingelheim Investigational Site 24	Kawagoe
Japan	Boehringer Ingelheim Investigational Site 46	Kawasaki
Japan	Boehringer Ingelheim Investigational Site 111	Kawatana
Japan	Boehringer Ingelheim Investigational Site 112	Kawatana
Japan	Boehringer Ingelheim Investigational Site 99	Kitakyushu
Japan	Boehringer Ingelheim Investigational Site 117	Kiyotake
Japan	Boehringer Ingelheim Investigational Site 83	Kobe
Japan	Boehringer Ingelheim Investigational Site 67	Koga
Japan	Boehringer Ingelheim Investigational Site 63	Konan
Japan	Boehringer Ingelheim Investigational Site 12	Koriyama
Japan	Boehringer Ingelheim Investigational Site 13	Koriyama
Japan	Boehringer Ingelheim Investigational Site 21	Koshiagya
Japan	Boehringer Ingelheim Investigational Site 100	Kurume
Japan	Boehringer Ingelheim Investigational Site 68	Kyoto
Japan	Boehringer Ingelheim Investigational Site 69	Kyoto
Japan	Boehringer Ingelheim Investigational Site 70	Kyoto
Japan	Boehringer Ingelheim Investigational Site 71	Kyoto
Japan	Boehringer Ingelheim Investigational Site 19	Maebashi
Japan	Boehringer Ingelheim Investigational Site 20	Maebashi
Japan	Boehringer Ingelheim Investigational Site 55	Matsumoto
Japan	Boehringer Ingelheim Investigational Site 88	Mihara
Japan	Boehringer Ingelheim Investigational Site 54	Minobu
Japan	Boehringer Ingelheim Investigational Site 116	Miyakonojo
Japan	Boehringer Ingelheim Investigational Site 114	Miyazaki
Japan	Boehringer Ingelheim Investigational Site 115	Miyazaki
Japan	Boehringer Ingelheim Investigational Site 77	Moriguchi
Japan	Boehringer Ingelheim Investigational Site 9	Morioka
Japan	Boehringer Ingelheim Investigational Site 23	Moroyama
Japan	Boehringer Ingelheim Investigational Site 4	Muroran
Japan	Boehringer Ingelheim Investigational Site 51	Nagaoka
Japan	Boehringer Ingelheim Investigational Site 61	Nagoya
Japan	Boehringer Ingelheim Investigational Site 62	Nagoya
Japan	Boehringer Ingelheim Investigational Site 97	Nangoku
Japan	Boehringer Ingelheim Investigational Site 102	Naoetsu
Japan	Boehringer Ingelheim Investigational Site 28	Narita
Japan	Boehringer Ingelheim Investigational Site 93	Naruto
Japan	Boehringer Ingelheim Investigational Site 17	Nikko
Japan	Boehringer Ingelheim Investigational Site 119	Nishihara
Japan	Boehringer Ingelheim Investigational Site 81	Nishinomiya
Japan	Boehringer Ingelheim Investigational Site 98	Okawa
Japan	Boehringer Ingelheim Investigational Site 72	Osaka
Japan	Boehringer Ingelheim Investigational Site 78	Osakasayama
Japan	Boehringer Ingelheim Investigational Site 66	Otsu
Japan	Boehringer Ingelheim Investigational Site 108	Saga
Japan	Boehringer Ingelheim Investigational Site 45	Sagamihara
Japan	Boehringer Ingelheim Investigational Site 22	Saitama
Japan	Boehringer Ingelheim Investigational Site 79	Sakai
Japan	Boehringer Ingelheim Investigational Site 52	Sanjo
Japan	Boehringer Ingelheim Investigational Site 90	Sanyoonoda
Japan	Boehringer Ingelheim Investigational Site 5	Sapporo
Japan	Boehringer Ingelheim Investigational Site 6	Sapporo
Japan	Boehringer Ingelheim Investigational Site 7	Sapporo
Japan	Boehringer Ingelheim Investigational Site 110	Sasebo
Japan	Boehringer Ingelheim Investigational Site 10	Sendai
Japan	Boehringer Ingelheim Investigational Site 91	Shimonoseki
Japan	Boehringer Ingelheim Investigational Site 18	Shimotsuke
Japan	Boehringer Ingelheim Investigational Site 85	Shingu
Japan	Boehringer Ingelheim Investigational Site 57	Shizuoka
Japan	Boehringer Ingelheim Investigational Site 58	Shizuoka
Japan	Boehringer Ingelheim Investigational Site 73	Suita
Japan	Boehringer Ingelheim Investigational Site 101	Tagawa
Japan	Boehringer Ingelheim Investigational Site 96	Takamatsu
Japan	Boehringer Ingelheim Investigational Site 74	Takatsuki
Japan	Boehringer Ingelheim Investigational Site 75	Takatsuki
Japan	Boehringer Ingelheim Investigational Site 109	Togitsu
Japan	Boehringer Ingelheim Investigational Site 92	Tokushima
Japan	Boehringer Ingelheim Investigational Site 30	Tokyo Adachi-ku
Japan	Boehringer Ingelheim Investigational Site 31	Tokyo Arakawa-ku
Japan	Boehringer Ingelheim Investigational Site 40	Tokyo Bunkyo-ku
Japan	Boehringer Ingelheim Investigational Site 41	Tokyo Bunkyo-ku
Japan	Boehringer Ingelheim Investigational Site 42	Tokyo Bunkyo-ku
Japan	Boehringer Ingelheim Investigational Site 38	Tokyo Chiyoda-ku
Japan	Boehringer Ingelheim Investigational Site 32	Tokyo Itabashi-ku
Japan	Boehringer Ingelheim Investigational Site 33	Tokyo Itabashi-ku
Japan	Boehringer Ingelheim Investigational Site 43	Tokyo Meguro-ku
Japan	Boehringer Ingelheim Investigational Site 39	Tokyo Nakano-ku
Japan	Boehringer Ingelheim Investigational Site 34	Tokyo Ota-ku
Japan	Boehringer Ingelheim Investigational Site 35	Tokyo Ota-ku
Japan	Boehringer Ingelheim Investigational Site 36	Tokyo Shinjuku-ku
Japan	Boehringer Ingelheim Investigational Site 37	Tokyo Shinjuku-ku
Japan	Boehringer Ingelheim Investigational Site 44	Tokyo Toshima-ku
Japan	Boehringer Ingelheim Investigational Site 113	Tomiai
Japan	Boehringer Ingelheim Investigational Site 14	Toride
Japan	Boehringer Ingelheim Investigational Site 65	Tsu
Japan	Boehringer Ingelheim Investigational Site 16	Tsukuba
Japan	Boehringer Ingelheim Investigational Site 53	Uchinada
Japan	Boehringer Ingelheim Investigational Site 29	Urayasu
Japan	Boehringer Ingelheim Investigational Site 84	Wakayama
Japan	Boehringer Ingelheim Investigational Site 89	Yamaguchi
Japan	Boehringer Ingelheim Investigational Site 47	Yokohama
Japan	Boehringer Ingelheim Investigational Site 48	Yokohama
Japan	Boehringer Ingelheim Investigational Site 94	Yoshinogawa

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events	The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.	during 36 months	Yes
Secondary	Clinical Global Impression of Improvement	Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).	after 36 months treatment	No
Secondary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score	Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.	Baseline and at 36 months (or at the time of discontinuation)	No
Secondary	Change From Baseline in Modified Hoehn & Yahr Rating Scale	A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).	Baseline and at 36 months (or at the time of discontinuation)	No