Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Mirapex PMS Study Final Report

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248168
• Other study ID #: 248.599
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: September 22, 2014
• Start date: March 2002

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1449
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

1. Patients who are hypersensitive to MIRAPEX or its ingredients

2. Refer to the insert paper for other contraindication.

• Following patients should be carefully administered.

1. Patient with renal impairment

2. Refer to the insert paper for other precaution.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Pramipexole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Unified Parkinson's disease Rating Scale (UPDRS)	Tremor at rest, Rigidity, Body bradykinesia and hypokinesia	up to 4 weeks	No
Secondary	Number of patients with adverse events		up to 4 weeks	No
Secondary	Global Assessment of efficacy by investigator on 3-point scale		after 4 weeks	No

External Links

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