Special Survey on PD Patients Treated Long-term Use of Pramipexole

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615914
First received: January 31, 2008
Last updated: May 18, 2012
Last verified: May 2012

January 31, 2008
May 18, 2012
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 ] [ 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.
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 ] [ 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).
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Special Survey on PD 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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Parkinson's disease patients in daily clinical settings

Parkinson Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1645
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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

Both
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No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00615914
248.547
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Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP