Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole
|ClinicalTrials.gov Identifier: NCT00615914|
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : November 23, 2010
Last Update Posted : July 11, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1645 participants|
|Official Title:||Pramipexole Special Survey on Long-Term Use|
|Study Start Date :||February 2004|
|Primary Completion Date :||March 2009|
- Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events [ Time Frame: during 18 months ]The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.
- Clinical Global Impression of Improvement [ Time Frame: 18 months ]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 18 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 18 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615914
Show 273 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|