Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

This study has been completed.

First Received on November 9, 2007.  
Last Updated on February 12, 2009  
History of Changes
This Clinical Trial Sponsored By: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals Identifier: NCT00557258

Purpose for Clinical Trial

The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care practices in Germany. The study will be conducted on a fixed day in November 2007.

Primary care surgeries throughout Germany will be asked to take part. The study material will be delivered to the surgery by a member of sales-force who will also explain the study conduct to the physician/staff. Physicians who want to take part in the study will send a signed contract to BI. Physicians will be trained to diagnose RLS.

All patients attending the participating surgeries on a fixed day will be invited to participate in the study. The patients will be handed a questionnaire to fill out while waiting for their appointment. No patient-related data apart from gender and year of birth will be recorded on the questionnaire and it will be ensured that no re-identification of patients is possible. Therefore, no written informed consent will be obtained from the participants.

The patient questionnaire will consist of the following items:

A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file) Additional questions concerning the impact of the patients leg problems on daily life.

The practice staff will then collect the questionnaire. All patients who have answered question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be assessed for the diagnosis by the physician.

The physician fills out a second questionnaire, covering the following items:

Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed questionnaires will be sent to data management by the surgery within 2 working days.

Restless Legs Syndrome

Study Type: Observational
Official Title: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

Resource links provided by NLM:

MedlinePlus related topics:
Restless Legs

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 14956
Study Start Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients attending one of the participating primary care surgeries on a fixed day
  • Male or female patients of any age

Exclusion Criteria:

  • Patients who only attend the practice to get a prescription and are not seen by the doctor on that day.
  • Patients who are not able to understand the questionnaire due to mental impairment or language problems.
  • Children and adolescents under the age of 18 years
  Contacts and Locations

Please refer to this study by its identifier: NCT00557258

Show 251 Study Locations

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00557258    
History of Changes
Other Study ID Numbers: 248.652
Study First Received: November 9, 2007
Last Updated: February 12, 2009
Health Authority: Germany: Ethik-Kommission der Ärztekammer Bremen Ethik-Komission der Landesärztekammer Hessen Ethik-Komission der Ärztekammer Nordrhein
United States: Food and Drug Administration

Additional relevant MeSH terms:

Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Sleep Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms processed this record on August 21, 2012

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