Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa
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|ClinicalTrials.gov Identifier: NCT00613301|
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : November 23, 2010
Last Update Posted : June 6, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||416 participants|
|Official Title:||Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa|
|Study Start Date :||February 2004|
|Primary Completion Date :||September 2009|
- Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events [ Time Frame: 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.
- Clinical Global Impression of Improvement [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613301
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|