Pramipexole Special Survey on Long-Term Use

Boehringer Ingelheim1 site in 1 country1,645 target enrollmentFebruary 2004

ConditionsParkinson Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 1645
Locations: 1
Primary Endpoint: Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

March 2009

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•Patients with Parkinson's disease

Exclusion Criteria

•Patients should have been treated according to the Japanese insert slip

Outcomes

Primary Outcomes

Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events

Time Frame: during 18 months

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 Outcomes

Clinical Global Impression of Improvement(18 months)
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score(Baseline and at 18 months (or at the time of discontinuation))
Change From Baseline in Modified Hoehn & Yahr Rating Scale(Baseline and at 18 months (or at the time of discontinuation))