We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615914
First Posted: February 14, 2008
Last Update Posted: July 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
January 31, 2008
February 14, 2008
September 8, 2010
November 23, 2010
July 11, 2014
February 2004
March 2009   (Final data collection date for primary outcome measure)
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.
Safety (Adverse event, Laboratory test) Efficacy (UPDRS part III, Clinical groval impression) [ Time Frame: 18 Months ]
Complete list of historical versions of study NCT00615914 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole
Pramipexole Special Survey on Long-Term Use
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Parkinson's disease patients in daily clinical settings
Parkinson Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1645
Not Provided
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with Parkinson's disease

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00615914
248.547
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2014