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.
Study Type
OBSERVATIONAL
Enrollment
416
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.
Time frame: during 36 months
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).
Time frame: after 36 months treatment
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.
Time frame: Baseline and at 36 months (or at the time of discontinuation)
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).
Time frame: Baseline and at 36 months (or at the time of discontinuation)
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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
...and 109 more locations