Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00613301
First received: January 31, 2008
Last updated: May 28, 2014
Last verified: May 2014
  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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events [ Time Frame: during 36 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.


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 Unified Parkinson's Disease Rating Scale (UPDRS) 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 described 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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 28, 2014
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 September 18, 2014