Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa|
- Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events [ Time Frame: during 36 months ] [ Designated as safety issue: Yes ]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.
- Clinical Global Impression of Improvement [ Time Frame: after 36 months treatment ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and at 36 months (or at the time of discontinuation) ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and at 36 months (or at the time of discontinuation) ] [ Designated as safety issue: No ]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).
|Study Start Date:||February 2004|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613301
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|