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

Mirapex PMS Study Final Report

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02248168
Enrollment
1449
Registered
2014-09-25
Start date
2002-03-31
Completion date
Unknown
Last updated
2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief 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

Interventions

DRUGPramipexole

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Unified Parkinson's disease Rating Scale (UPDRS)up to 4 weeksTremor at rest, Rigidity, Body bradykinesia and hypokinesia

Secondary

MeasureTime frame
Number of patients with adverse eventsup to 4 weeks
Global Assessment of efficacy by investigator on 3-point scaleafter 4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026