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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01174459
First received: August 2, 2010
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition
Restless Legs Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of Drug-related Adverse Events [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Number of patients with drug-related adverse events


Secondary Outcome Measures:
  • Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS) [ Time Frame: after 12 months or at the end of observation ] [ Designated as safety issue: No ]
    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.


Enrollment: 571
Study Start Date: August 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient with Restless Legs Syndrome

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

500

Criteria

Inclusion criteria:

Patient with Restless Legs Syndrome

Exclusion criteria:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174459

  Show 159 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01174459     History of Changes
Other Study ID Numbers: 248.678
Study First Received: August 2, 2010
Results First Received: July 9, 2014
Last Updated: August 28, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014