Special Survey on PD Patients Treated Long-term Use of Pramipexole
This study has been completed.
Information provided by:
First received: January 31, 2008
Last updated: May 18, 2012
Last verified: May 2012
The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pramipexole Special Survey on Long-Term Use|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events [ Time Frame: during 18 months ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Clinical Global Impression of Improvement [ Time Frame: 18 months ] [ 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 UPDRS (Unified Parkinson's Disease Rating Scale) Part III Total Score [ Time Frame: Baseline and at 18 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 18 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 decribed 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:||March 2009 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615914
Show 273 Study Locations
Show 273 Study Locations
Sponsors and Collaborators
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|