Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT01170091
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

Detailed Description

Study Design:

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2011-02
• Results First Submitted: 2012-06-27
• Results First Submitted QC: 2012-08-09
• Results First Posted: 2012-09-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 651

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Reported Adverse Events	Up to 4 weeks	If there is a dose titration, another 4 weeks should be followed up

Secondary Outcome Measures

Name	Time	Method
International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment	before and after the treatment with Mirapex (at least 4 weeks after the end of titration)	a change in 10-item scale rated by the patient on 5 levels with a minimum ("none") sum score of 0 to maximum ("very severe") sum score of 40
Patient-Global Impressions (PGI-I)	before and after the treatment with Mirapex (at least 4 weeks after the end of titration)	PGI comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."
Clinical Global Impressions-Global Improvement (CGI-I)	before and after the treatment with Mirapex (at least 4 weeks after the end of titration)	CGI-I comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."

Trial Locations

Locations (36)

Boehringer Ingelheim Investigational Site 1; 🇰🇷 Busan, Korea, Republic of

Boehringer Ingelheim Investigational Site 2; 🇰🇷 Busan, Korea, Republic of

Boehringer Ingelheim Investigational Site 3; 🇰🇷 Busan, Korea, Republic of

Boehringer Ingelheim Investigational Site 32; 🇰🇷 Daegu, Korea, Republic of

Boehringer Ingelheim Investigational Site 33; 🇰🇷 Daegu, Korea, Republic of

Boehringer Ingelheim Investigational Site 34; 🇰🇷 Daejeon, Korea, Republic of

Boehringer Ingelheim Investigational Site 35; 🇰🇷 Daejeon, Korea, Republic of

Boehringer Ingelheim Investigational Site 36; 🇰🇷 Deajeon, Korea, Republic of

Boehringer Ingelheim Investigational Site 25; 🇰🇷 Gwangju, Korea, Republic of

Boehringer Ingelheim Investigational Site 26; 🇰🇷 Gwangju, Korea, Republic of

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