Restless Legs SyndromeNCT00557258

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

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 251 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Restless Legs Syndrome
How many people: 14,956 participants
Where: 251 sitesGermany
Study dates: Nov 2007to Nov 2007
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

251 sites in 1 country.

City, postcode or hospital

251 sites in 1 country

Germany251 sites

Boehringer Ingelheim Investigational Site
Aachen
Boehringer Ingelheim Investigational Site
Aalen
Boehringer Ingelheim Investigational Site
Ahlen
Boehringer Ingelheim Investigational Site
Altena
Boehringer Ingelheim Investigational Site
Altensteig
Boehringer Ingelheim Investigational Site
Altomünster
Boehringer Ingelheim Investigational Site
Alveslohe
Boehringer Ingelheim Investigational Site
Annaberg-Buchholz
Boehringer Ingelheim Investigational Site
Apolda
Boehringer Ingelheim Investigational Site
Artern
Boehringer Ingelheim Investigational Site
Aschersleben
Boehringer Ingelheim Investigational Site
Aub
Boehringer Ingelheim Investigational Site
Babenhausen
Boehringer Ingelheim Investigational Site
Bad Bevensen
Boehringer Ingelheim Investigational Site
Bad Buchau
Boehringer Ingelheim Investigational Site
Bad Essen
Boehringer Ingelheim Investigational Site
Bad Krozingen
Boehringer Ingelheim Investigational Site
Bad Laasphe
Boehringer Ingelheim Investigational Site
Bad Langensalza
Boehringer Ingelheim Investigational Site
Bad Schussenried
Boehringer Ingelheim Investigational Site
Bautzen
Boehringer Ingelheim Investigational Site
Bergholz-Rehbrücke
Boehringer Ingelheim Investigational Site
Berlin
Boehringer Ingelheim Investigational Site
Bernburg
Boehringer Ingelheim Investigational Site
Bernsdorf
Boehringer Ingelheim Investigational Site
Bevern
Boehringer Ingelheim Investigational Site
Biberach
Boehringer Ingelheim Investigational Site
Bienenbüttel
Boehringer Ingelheim Investigational Site
Birkenwerder
Boehringer Ingelheim Investigational Site
Bisingen
Boehringer Ingelheim Investigational Site
Bodelshausen
Boehringer Ingelheim Investigational Site
Bodenwöhr
Boehringer Ingelheim Investigational Site
Bornheim
Boehringer Ingelheim Investigational Site
Braunschweig
Boehringer Ingelheim Investigational Site
Bremen
Boehringer Ingelheim Investigational Site
Bückeburg
Boehringer Ingelheim Investigational Site
Buckenhof
Boehringer Ingelheim Investigational Site
Buedelsdorf
Boehringer Ingelheim Investigational Site
Bünde
Boehringer Ingelheim Investigational Site
Burgdorf, Hanover
Boehringer Ingelheim Investigational Site
Burgheim
Boehringer Ingelheim Investigational Site
Burgoberbach
Boehringer Ingelheim Investigational Site
Calbe
Boehringer Ingelheim Investigational Site
Calw
Boehringer Ingelheim Investigational Site
Castrop-Rauxel
Boehringer Ingelheim Investigational Site
Celle
Boehringer Ingelheim Investigational Site
Chemnitz
Boehringer Ingelheim Investigational Site
Cologne
Boehringer Ingelheim Investigational Site
Coppenbrügge
Boehringer Ingelheim Investigational Site
Cottbus
Boehringer Ingelheim Investigational Site
Cuxhaven
Boehringer Ingelheim Investigational Site
Dänischenhagen
Boehringer Ingelheim Investigational Site
Daun
Boehringer Ingelheim Investigational Site
Delligsen
Boehringer Ingelheim Investigational Site
Denkendorf
Boehringer Ingelheim Investigational Site
Dillingen
Boehringer Ingelheim Investigational Site
Donauwörth
Boehringer Ingelheim Investigational Site
Dörentrup
Boehringer Ingelheim Investigational Site
Dormagen
Boehringer Ingelheim Investigational Site
Dorn-Dürkheim
Boehringer Ingelheim Investigational Site
Dortmund
Boehringer Ingelheim Investigational Site
Dreieich
Boehringer Ingelheim Investigational Site
Dresden
Boehringer Ingelheim Investigational Site
Duisburg
Boehringer Ingelheim Investigational Site
Düren
Boehringer Ingelheim Investigational Site
Düsseldorf
Boehringer Ingelheim Investigational Site
Edenkoben
Boehringer Ingelheim Investigational Site
Eisingen
Boehringer Ingelheim Investigational Site
Elsenfeld
Boehringer Ingelheim Investigational Site
Emsdetten
Boehringer Ingelheim Investigational Site
Eppelheim
Boehringer Ingelheim Investigational Site
Erftstadt
Boehringer Ingelheim Investigational Site
Erfurt
Boehringer Ingelheim Investigational Site
Erlangen
Boehringer Ingelheim Investigational Site
Erndtebrück
Boehringer Ingelheim Investigational Site
Eschau
Boehringer Ingelheim Investigational Site
Essen
Boehringer Ingelheim Investigational Site
Esslingen am Neckar
Boehringer Ingelheim Investigational Site
Eutin
Boehringer Ingelheim Investigational Site
Extertal
Boehringer Ingelheim Investigational Site
Falkensee
Boehringer Ingelheim Investigational Site
Frankfurt
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site
Freising
Boehringer Ingelheim Investigational Site
Friedenfels
Boehringer Ingelheim Investigational Site
Friedrichsthal
Boehringer Ingelheim Investigational Site
Fulda
Boehringer Ingelheim Investigational Site
Fürstenwalde
Boehringer Ingelheim Investigational Site
Geiselhöring
Boehringer Ingelheim Investigational Site
Gelsenkirchen
Boehringer Ingelheim Investigational Site
Gensingen
Boehringer Ingelheim Investigational Site
Germering
Boehringer Ingelheim Investigational Site
Gladbeck
Boehringer Ingelheim Investigational Site
Glashütten
Boehringer Ingelheim Investigational Site
Göttingen
Boehringer Ingelheim Investigational Site
Greiz
Boehringer Ingelheim Investigational Site
Grömitz
Boehringer Ingelheim Investigational Site
Großenkneten
Boehringer Ingelheim Investigational Site
Großenlüder
Boehringer Ingelheim Investigational Site
Haag
Boehringer Ingelheim Investigational Site
Hagen
Boehringer Ingelheim Investigational Site
Halle
Boehringer Ingelheim Investigational Site
Haltern
Boehringer Ingelheim Investigational Site
Hamburg
Boehringer Ingelheim Investigational Site
Hamminkeln
Boehringer Ingelheim Investigational Site
Hanerau-Hademarschen
Boehringer Ingelheim Investigational Site
Hanover
Boehringer Ingelheim Investigational Site
Harsewinkel
Boehringer Ingelheim Investigational Site
Hartenstein
Boehringer Ingelheim Investigational Site
Hattorf
Boehringer Ingelheim Investigational Site
Heilbronn
Boehringer Ingelheim Investigational Site
Heinsberg
Boehringer Ingelheim Investigational Site
Herbertshofen
Boehringer Ingelheim Investigational Site
Herbrechtingen
Boehringer Ingelheim Investigational Site
Hermsdorf
Boehringer Ingelheim Investigational Site
Hohenhameln
Boehringer Ingelheim Investigational Site
Hosena
Boehringer Ingelheim Investigational Site
Hude
Boehringer Ingelheim Investigational Site
Ippesheim
Boehringer Ingelheim Investigational Site
Ispringen
Boehringer Ingelheim Investigational Site
Jahnsdorf
Boehringer Ingelheim Investigational Site
Jever
Boehringer Ingelheim Investigational Site
Jühnde
Boehringer Ingelheim Investigational Site
Jünkerath
Boehringer Ingelheim Investigational Site
Kahl am Main
Boehringer Ingelheim Investigational Site
Kalbach
Boehringer Ingelheim Investigational Site
Kamen
Boehringer Ingelheim Investigational Site
Kassel
Boehringer Ingelheim Investigational Site
Katzhütte
Boehringer Ingelheim Investigational Site
Kaufbeuren
Boehringer Ingelheim Investigational Site
Kirchardt
Boehringer Ingelheim Investigational Site
Kirchheim
Boehringer Ingelheim Investigational Site
Kirchlengern
Boehringer Ingelheim Investigational Site
Kitzingen
Boehringer Ingelheim Investigational Site
Kressbronn
Boehringer Ingelheim Investigational Site
Kronach
Boehringer Ingelheim Investigational Site
Kropp
Boehringer Ingelheim Investigational Site
Krumbach
Boehringer Ingelheim Investigational Site
Kuppenheim
Boehringer Ingelheim Investigational Site
Laatzen
Boehringer Ingelheim Investigational Site
Lahnau
Boehringer Ingelheim Investigational Site
Lahr
Boehringer Ingelheim Investigational Site
Lampertheim
Boehringer Ingelheim Investigational Site
Langen
Boehringer Ingelheim Investigational Site
Langenfeld
Boehringer Ingelheim Investigational Site
Lauf
Boehringer Ingelheim Investigational Site
Leer
Boehringer Ingelheim Investigational Site
Lehrberg
Boehringer Ingelheim Investigational Site
Leipzig
Boehringer Ingelheim Investigational Site
Lengefeld
Boehringer Ingelheim Investigational Site
Leonberg
Boehringer Ingelheim Investigational Site
Leverkusen
Boehringer Ingelheim Investigational Site
Lienen
Boehringer Ingelheim Investigational Site
Lohfelden
Boehringer Ingelheim Investigational Site
Lohra
Boehringer Ingelheim Investigational Site
Lüderitz
Boehringer Ingelheim Investigational Site
Ludwigshafen
Boehringer Ingelheim Investigational Site
Lunzenau
Boehringer Ingelheim Investigational Site
Lütjenburg
Boehringer Ingelheim Investigational Site
Magdeburg
Boehringer Ingelheim Investigational Site
Mannheim
Boehringer Ingelheim Investigational Site
Marburg
Boehringer Ingelheim Investigational Site
Meerbusch
Boehringer Ingelheim Investigational Site
Meldorf
Boehringer Ingelheim Investigational Site
Mendig
Boehringer Ingelheim Investigational Site
Mengkofen
Boehringer Ingelheim Investigational Site
Meßstetten
Boehringer Ingelheim Investigational Site
Mindelheim
Boehringer Ingelheim Investigational Site
Mittweida
Boehringer Ingelheim Investigational Site
Mönchengladbach
Boehringer Ingelheim Investigational Site
Moosburg
Boehringer Ingelheim Investigational Site
Mosbach
Boehringer Ingelheim Investigational Site
Mühlhausen
Boehringer Ingelheim Investigational Site
Mülheim
Boehringer Ingelheim Investigational Site
München
Boehringer Ingelheim Investigational Site
Niederndodeleben
Boehringer Ingelheim Investigational Site
Nienburg
Boehringer Ingelheim Investigational Site
Nuremberg
Boehringer Ingelheim Investigational Site
Oberdorla
Boehringer Ingelheim Investigational Site
Oberursel
Boehringer Ingelheim Investigational Site
Oer-Erkenschwick
Boehringer Ingelheim Investigational Site
Olbernhau
Boehringer Ingelheim Investigational Site
Olfen
Boehringer Ingelheim Investigational Site
Osnabrück
Boehringer Ingelheim Investigational Site
Ostrach
Boehringer Ingelheim Investigational Site
Parey
Boehringer Ingelheim Investigational Site
Petershagen
Boehringer Ingelheim Investigational Site
Pirmasens
Boehringer Ingelheim Investigational Site
Plattling
Boehringer Ingelheim Investigational Site
Pleidelsheim
Boehringer Ingelheim Investigational Site
Potsdam
Boehringer Ingelheim Investigational Site
Pulheim
Boehringer Ingelheim Investigational Site
Rastede
Boehringer Ingelheim Investigational Site
Remscheid
Boehringer Ingelheim Investigational Site
Rhaunen
Boehringer Ingelheim Investigational Site
Roggendorf
Boehringer Ingelheim Investigational Site
Rossau
Boehringer Ingelheim Investigational Site
Rostock
Boehringer Ingelheim Investigational Site
Röthenbach
Boehringer Ingelheim Investigational Site
Saerbeck
Boehringer Ingelheim Investigational Site
Schönau
Boehringer Ingelheim Investigational Site
Schönebeck
Boehringer Ingelheim Investigational Site
Schorndorf
Boehringer Ingelheim Investigational Site
Schwäbisch Gmünd
Boehringer Ingelheim Investigational Site
Schwarzenbach A Wald
Boehringer Ingelheim Investigational Site
Schwerte
Boehringer Ingelheim Investigational Site
Seelow
Boehringer Ingelheim Investigational Site
Selfkant
Boehringer Ingelheim Investigational Site
Senftenberg
Boehringer Ingelheim Investigational Site
Siegen
Boehringer Ingelheim Investigational Site
Sögel
Boehringer Ingelheim Investigational Site
Solingen
Boehringer Ingelheim Investigational Site
Sonsbeck
Boehringer Ingelheim Investigational Site
Speyer
Boehringer Ingelheim Investigational Site
Sprendlingen
Boehringer Ingelheim Investigational Site
Stadland
Boehringer Ingelheim Investigational Site
Stadthagen
Boehringer Ingelheim Investigational Site
Straubing
Boehringer Ingelheim Investigational Site
Stuhr
Boehringer Ingelheim Investigational Site
Stutensee
Boehringer Ingelheim Investigational Site
Stuttgart
Boehringer Ingelheim Investigational Site
Suhl
Boehringer Ingelheim Investigational Site
Sulzbach
Boehringer Ingelheim Investigational Site
Sulzbach-Rosenberg
Boehringer Ingelheim Investigational Site
Teterow
Boehringer Ingelheim Investigational Site
Tettnang
Boehringer Ingelheim Investigational Site
Thaleischweiler-Fröschen
Boehringer Ingelheim Investigational Site
Troisdorf
Boehringer Ingelheim Investigational Site
Veilsdorf
Boehringer Ingelheim Investigational Site
Vellahn
Boehringer Ingelheim Investigational Site
Viernheim
Boehringer Ingelheim Investigational Site
Villingen-Schwenningen
Boehringer Ingelheim Investigational Site
Waghäusel
Boehringer Ingelheim Investigational Site
Wehrsdorf
Boehringer Ingelheim Investigational Site
Weibern
Boehringer Ingelheim Investigational Site
Weimar
Boehringer Ingelheim Investigational Site
Welzheim
Boehringer Ingelheim Investigational Site
Wemding
Boehringer Ingelheim Investigational Site
Wertingen
Boehringer Ingelheim Investigational Site
Wesel
Boehringer Ingelheim Investigational Site
Wesseling
Boehringer Ingelheim Investigational Site
Wetzendorf
Boehringer Ingelheim Investigational Site
Wetzlar
Boehringer Ingelheim Investigational Site
Wickede
Boehringer Ingelheim Investigational Site
Wiesbaden
Boehringer Ingelheim Investigational Site
Winsen
Boehringer Ingelheim Investigational Site
Wöbbelin
Boehringer Ingelheim Investigational Site
Zschocken
Boehringer Ingelheim Investigational Site
Zschopau
Boehringer Ingelheim Investigational Site
Zweibrücken
Boehringer Ingelheim Investigational Site
Zwickau

Other trials in Germany

About this study

Official title: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

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.

Conditions: Restless Legs Syndrome
Medical subject headings: Restless Legs Syndrome

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Nov 2007

First posted12 Nov 2007 (estimated)
Study startNov 2007
Primary completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Enrolment: 14,956 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00557258
Sponsor's protocol ID: 248.652
Status last verified: Feb 2009
First submitted: 9 Nov 2007
Last updated: 13 Feb 2009
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)

All Restless Legs Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs
ClinicalTrials.gov ID: NCT00557258
Acronym / sponsor ID: 248.652
Conditions: Restless Legs Syndrome
Study type: Observational
Recruitment status: Completed
Enrolment: 14,956 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Nov 2007 (actual)
First posted: 12 Nov 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.

Related trials for Restless Legs Syndrome

RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

251 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 251 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 251 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00557258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2009.