Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT00615914
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Primary Completion: 2009-03
• Results First Submitted: 2010-09-08
• Results First Submitted QC: 2010-10-26
• Results First Posted: 2010-11-23
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1645

Inclusion Criteria

Patients with Parkinson's disease

Exclusion Criteria

Patients should have been treated according to the Japanese insert slip

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events	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 Outcome Measures

Name	Time	Method
Clinical Global Impression of Improvement	18 months	Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
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)	Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.
Change From Baseline in Modified Hoehn & Yahr Rating Scale	Baseline and at 18 months (or at the time of discontinuation)	A severity of PD symptom are assessed by Modified Hoehn \& Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇯🇵 Zama, Japan