Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT01174459
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2014-07-09
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-28
• Last Update Submitted: 2014-08-28
• Results First Posted: 2014-08-29
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 571

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Drug-related Adverse Events	12 Months	Number of patients with drug-related adverse events

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)	after 12 months or at the end of observation	International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.

Trial Locations

Locations (159)

Boehringer Ingelheim Investigational Site 119; 🇯🇵 Akashi, Japan

Boehringer Ingelheim Investigational Site 52; 🇯🇵 Akishima, Japan

Boehringer Ingelheim Investigational Site 16; 🇯🇵 Akita, Japan

Boehringer Ingelheim Investigational Site 22; 🇯🇵 Ami-machi, Japan

Boehringer Ingelheim Investigational Site 1; 🇯🇵 Asahikawa, Japan

Boehringer Ingelheim Investigational Site 36; 🇯🇵 Asahi, Japan

Boehringer Ingelheim Investigational Site 40; 🇯🇵 Chiba, Japan

Boehringer Ingelheim Investigational Site 158; 🇯🇵 Chofu, Japan

Boehringer Ingelheim Investigational Site 78; 🇯🇵 Chuo, Japan

Boehringer Ingelheim Investigational Site 66; 🇯🇵 Fujisawa, Japan

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