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

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ClinicalTrials.gov Identifier: NCT01174459
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Restless Legs Syndrome

Study Type : Observational
Actual Enrollment : 571 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Study Start Date : August 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Group/Cohort
Patient with Restless Legs Syndrome



Primary Outcome Measures :
  1. Incidence of Drug-related Adverse Events [ Time Frame: 12 Months ]
    Number of patients with drug-related adverse events


Secondary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
500
Criteria

Inclusion criteria:

Patient with Restless Legs Syndrome

Exclusion criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174459


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01174459     History of Changes
Other Study ID Numbers: 248.678
First Posted: August 3, 2010    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014
Last Verified: August 2014

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 Wake Disorders
Parasomnias
Mental Disorders