Special Survey on PD Patients Treated Long-term Use of Pramipexole
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00615914
First received: January 31, 2008
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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 |
|---|
|
Parkinson Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pramipexole Special Survey on Long-Term Use |
Resource links provided by NLM:
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 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:
- 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).
| Enrollment: | 1645 |
| Study Start Date: | February 2004 |
| Primary Completion Date: | March 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
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: NCT00615914
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| Boehringer Ingelheim Investigational Site | |
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Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00615914 History of Changes |
| Other Study ID Numbers: | 248.547 |
| 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 Pramipexol Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 19, 2013