- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02248168
Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease
September 22, 2014 updated by: Boehringer Ingelheim
Mirapex PMS Study Final Report
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.
- Unexpected adverse events (especially, serious adverse events (SAEs))
- To find out the status of incidence of adverse events under actual practice
- Factors on the safety profile
- Factors on the efficacy profile
Study Overview
Study Type
Observational
Enrollment (Actual)
1449
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with idiopathic Parkinson's disease
Description
Inclusion Criteria:
- Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping
Exclusion Criteria:
Following patients are contraindicated.
- Patients who are hypersensitive to MIRAPEX or its ingredients
- Refer to the insert paper for other contraindication.
Following patients should be carefully administered.
- Patient with renal impairment
- Refer to the insert paper for other precaution.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Idiopathic Parkinson's disease patients
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Unified Parkinson's disease Rating Scale (UPDRS)
Time Frame: up to 4 weeks
|
Tremor at rest, Rigidity, Body bradykinesia and hypokinesia
|
up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Global Assessment of efficacy by investigator on 3-point scale
Time Frame: after 4 weeks
|
after 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Primary Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
September 22, 2014
First Submitted That Met QC Criteria
September 22, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Estimate)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 22, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Dopamine Agonists
- Dopamine Agents
- Antioxidants
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pramipexole
Other Study ID Numbers
- 248.599
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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