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

Boehringer Ingelheim1,449 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,449

Conditions

Parkinson Disease

Interventions

PramipexoleDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Assessment of Unified Parkinson's disease Rating Scale (UPDRS)

Tremor at rest, Rigidity, Body bradykinesia and hypokinesia

Time frame: up to 4 weeks

Secondary Outcomes

Number of patients with adverse events

Time frame: up to 4 weeks

Global Assessment of efficacy by investigator on 3-point scale

Time frame: after 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.