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Special Survey on PD Patients Without Concomitant Use of L-Dopa

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00613301
First received: January 31, 2008
Last updated: May 18, 2012
Last verified: May 2012
History of Changes

January 31, 2008
May 18, 2012
February 2004
September 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 safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years. Therefore these items were considered as a safety evaluation.
Safety (Adverse event, Laboratory test) Efficacy (UPDRS part III, Clinical groval impression) [ Time Frame: 3 Years ]
Complete list of historical versions of study NCT00613301 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression of Improvement [ Time Frame: after 36 months treatment ] [ 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 36 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 36 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 Without Concomitant Use of L-Dopa
Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa

The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the 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
416
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September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with Parkinson's disease who do not receive L-Dopa supplementation

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
 
NCT00613301
248.549
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Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2012

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