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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
  Purpose

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.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 416
Study Start Date: February 2004
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Parkinson's disease patients in daily clinical settings

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613301

  Show 119 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00613301     History of Changes
Other Study ID Numbers: 248.549
Study First Received: January 31, 2008
Results First Received: September 8, 2010
Last Updated: May 18, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013