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

Completed

Brief 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 & 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

Primary Outcome Measures

Name	Time	Method
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events	during 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Improvement	after 36 months treatment	Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score	Baseline and at 36 months (or at the time of discontinuation)	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.
Change From Baseline in Modified Hoehn & Yahr Rating Scale	Baseline and at 36 months (or at the time of discontinuation)	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).

Locations (119): Boehringer Ingelheim Investigational Site 11
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Akita, Japan
Boehringer Ingelheim Investigational Site 95
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Anan, Japan
Boehringer Ingelheim Investigational Site 1
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Asahikawa, Japan
Boehringer Ingelheim Investigational Site 2
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Asahikawa, Japan
Boehringer Ingelheim Investigational Site 26
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Chiba, Japan
Boehringer Ingelheim Investigational Site 27
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Chiba, Japan
Boehringer Ingelheim Investigational Site 49
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Fujisawa, Japan
Boehringer Ingelheim Investigational Site 60
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Fuji, Japan
Boehringer Ingelheim Investigational Site 25
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Fukaya, Japan
Boehringer Ingelheim Investigational Site 103
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Fukuoka, Japan
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Boehringer Ingelheim Investigational Site 11
🇯🇵Akita, Japan