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

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. Identifier: NCT00615914
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : November 23, 2010
Last Update Posted : July 11, 2014
Information provided by:
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease
Parkinson Disease

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Study Type : Observational
Actual Enrollment : 1645 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pramipexole Special Survey on Long-Term Use
Study Start Date : February 2004
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's disease patients in daily clinical settings

Inclusion Criteria:

Patients with Parkinson's disease

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615914

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00615914    
Other Study ID Numbers: 248.547
First Posted: February 14, 2008    Key Record Dates
Results First Posted: November 23, 2010
Last Update Posted: July 11, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents