Restless Legs SyndromeNCT00539461

Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 317 sites in Germany.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Restless Legs Syndrome
How many people: 2,023 participants
Where: 317 sitesGermany
Study dates: Feb 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

Study population: RLS patients

Who may be able to join

Diagnosis of primary RLS
Indication for RLS treatment with Sifrol® (pramipexole)
Male or female patients aged at least 18 years.

Who cannot join

Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
Ongoing treatment with Sifrol® (pramipexole).

Trial locations and contacts

317 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Germany300 sites

Boehringer Ingelheim Investigational Site
Aalen
Boehringer Ingelheim Investigational Site
Aarbergen
Boehringer Ingelheim Investigational Site
Adendorf
Boehringer Ingelheim Investigational Site
Aham
Boehringer Ingelheim Investigational Site
Ahaus
Boehringer Ingelheim Investigational Site
Ahlen
Boehringer Ingelheim Investigational Site
Ahorntal
Boehringer Ingelheim Investigational Site
Aichach
Boehringer Ingelheim Investigational Site
Aislingen
Boehringer Ingelheim Investigational Site
Albstadt
Boehringer Ingelheim Investigational Site
Aldenhoven
Boehringer Ingelheim Investigational Site
Aldingen
Boehringer Ingelheim Investigational Site
Alfeld
Boehringer Ingelheim Investigational Site
Alpirsbach
Boehringer Ingelheim Investigational Site
Alsdorf
Boehringer Ingelheim Investigational Site
Altena
Boehringer Ingelheim Investigational Site
Altenstadt
Boehringer Ingelheim Investigational Site
Altomünster
Boehringer Ingelheim Investigational Site
Alveslohe
Boehringer Ingelheim Investigational Site
Amberg
Boehringer Ingelheim Investigational Site
Ammerbuch
Boehringer Ingelheim Investigational Site
Andernach
Boehringer Ingelheim Investigational Site
Anklam
Boehringer Ingelheim Investigational Site
Apolda
Boehringer Ingelheim Investigational Site
Armsheim
Boehringer Ingelheim Investigational Site
Arzberg
Boehringer Ingelheim Investigational Site
Aschaffenburg
Boehringer Ingelheim Investigational Site
Aschersleben
Boehringer Ingelheim Investigational Site
Aschheim
Boehringer Ingelheim Investigational Site
Attendorn
Boehringer Ingelheim Investigational Site
Auerbach
Boehringer Ingelheim Investigational Site
Augsburg
Boehringer Ingelheim Investigational Site
Aurich
Boehringer Ingelheim Investigational Site
Babensham
Boehringer Ingelheim Investigational Site
Backnang
Boehringer Ingelheim Investigational Site
Bad Arolsen
Boehringer Ingelheim Investigational Site
Bad Berleburg
Boehringer Ingelheim Investigational Site
Bad Bevensen
Boehringer Ingelheim Investigational Site
Bad Düben
Boehringer Ingelheim Investigational Site
Bad Dürrenberg
Boehringer Ingelheim Investigational Site
Bad Dürrheim
Boehringer Ingelheim Investigational Site
Bad Ems
Boehringer Ingelheim Investigational Site
Bad Essen
Boehringer Ingelheim Investigational Site
Bad Kreuznach
Boehringer Ingelheim Investigational Site
Bad Laasphe
Boehringer Ingelheim Investigational Site
Bad Langensalza
Boehringer Ingelheim Investigational Site
Bad Lausick
Boehringer Ingelheim Investigational Site
Bad Münstereifel
Boehringer Ingelheim Investigational Site
Bad Oeynhausen
Boehringer Ingelheim Investigational Site
Bad Salzungen
Boehringer Ingelheim Investigational Site
Bad Schwalbach
Boehringer Ingelheim Investigational Site
Bad Schwartau
Boehringer Ingelheim Investigational Site
Bad Segeberg
Boehringer Ingelheim Investigational Site
Bad Tennstedt
Boehringer Ingelheim Investigational Site
Bad Waldsee
Boehringer Ingelheim Investigational Site
Baden-Baden
Boehringer Ingelheim Investigational Site
Bahrdorf
Boehringer Ingelheim Investigational Site
Baltmannsweiler
Boehringer Ingelheim Investigational Site
Bamberg
Boehringer Ingelheim Investigational Site
Barleben
Boehringer Ingelheim Investigational Site
Bärnau
Boehringer Ingelheim Investigational Site
Baunatal
Boehringer Ingelheim Investigational Site
Bautzen
Boehringer Ingelheim Investigational Site
Bayreuth
Boehringer Ingelheim Investigational Site
Beckum
Boehringer Ingelheim Investigational Site
Beeskow
Boehringer Ingelheim Investigational Site
Bellheim
Boehringer Ingelheim Investigational Site
Belm
Boehringer Ingelheim Investigational Site
Bensheim
Boehringer Ingelheim Investigational Site
Berching
Boehringer Ingelheim Investigational Site
Bergfelde
Boehringer Ingelheim Investigational Site
Bergheim
Boehringer Ingelheim Investigational Site
Bergisch Gladbach
Boehringer Ingelheim Investigational Site
Berkheim
Boehringer Ingelheim Investigational Site
Berlin
Boehringer Ingelheim Investigational Site
Berne
Boehringer Ingelheim Investigational Site
Bernsdorf
Boehringer Ingelheim Investigational Site
Betzdorf
Boehringer Ingelheim Investigational Site
Biebertal
Boehringer Ingelheim Investigational Site
Bielefeld
Boehringer Ingelheim Investigational Site
Bienenbüttel
Boehringer Ingelheim Investigational Site
Bippen
Boehringer Ingelheim Investigational Site
Birkenfeld
Boehringer Ingelheim Investigational Site
Birkenwerder
Boehringer Ingelheim Investigational Site
Blankenhain
Boehringer Ingelheim Investigational Site
Blaustein
Boehringer Ingelheim Investigational Site
Blieskastel
Boehringer Ingelheim Investigational Site
Bobritzsch
Boehringer Ingelheim Investigational Site
Bocholt
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Bochum
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Bockenem
Boehringer Ingelheim Investigational Site
Bodelshausen
Boehringer Ingelheim Investigational Site
Bodenfelde
Boehringer Ingelheim Investigational Site
Bodenkirchen
Boehringer Ingelheim Investigational Site
Bodenwöhr
Boehringer Ingelheim Investigational Site
Bodman-Ludwigshafen
Boehringer Ingelheim Investigational Site
Böhlen
Boehringer Ingelheim Investigational Site
Bollendorf
Boehringer Ingelheim Investigational Site
Bonn
Boehringer Ingelheim Investigational Site
Bopfingen
Boehringer Ingelheim Investigational Site
Borgholzhausen
Boehringer Ingelheim Investigational Site
Borken
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Borna
Boehringer Ingelheim Investigational Site
Bornheim
Boehringer Ingelheim Investigational Site
Bösel
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Bottendorf
Boehringer Ingelheim Investigational Site
Bottmersdorf
Boehringer Ingelheim Investigational Site
Bottrop
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Bovenden
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Brake
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Brandenburg
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Brannenburg
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Braunschweig
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Brechen
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Breitenbrunn
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Bremen
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Bremerhaven
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Brensbach
Boehringer Ingelheim Investigational Site
Breuberg
Boehringer Ingelheim Investigational Site
Bruchköbel
Boehringer Ingelheim Investigational Site
Brunsbüttel
Boehringer Ingelheim Investigational Site
Buchbach
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Bückeburg
Boehringer Ingelheim Investigational Site
Buckow
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Buedelsdorf
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Bünde
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Burg
Boehringer Ingelheim Investigational Site
Burgau
Boehringer Ingelheim Investigational Site
Burgdorf, Hanover
Boehringer Ingelheim Investigational Site
Burgpreppach
Boehringer Ingelheim Investigational Site
Burtenbach
Boehringer Ingelheim Investigational Site
Büttelborn
Boehringer Ingelheim Investigational Site
Buttstädt
Boehringer Ingelheim Investigational Site
Butzbach
Boehringer Ingelheim Investigational Site
Cadolzburg
Boehringer Ingelheim Investigational Site
Calbe
Boehringer Ingelheim Investigational Site
Calberlah
Boehringer Ingelheim Investigational Site
Castrop-Rauxel
Boehringer Ingelheim Investigational Site
Celle
Boehringer Ingelheim Investigational Site
Chemnitz
Boehringer Ingelheim Investigational Site
Cochem
Boehringer Ingelheim Investigational Site
Coppenbrügge
Boehringer Ingelheim Investigational Site
Crimmitschau
Boehringer Ingelheim Investigational Site
Crivitz
Boehringer Ingelheim Investigational Site
Cuxhaven
Boehringer Ingelheim Investigational Site
Dabel
Boehringer Ingelheim Investigational Site
Darmstadt
Boehringer Ingelheim Investigational Site
Dassow
Boehringer Ingelheim Investigational Site
Datteln
Boehringer Ingelheim Investigational Site
Daun
Boehringer Ingelheim Investigational Site
Deggendorf
Boehringer Ingelheim Investigational Site
Deidesheim
Boehringer Ingelheim Investigational Site
Deining
Boehringer Ingelheim Investigational Site
Delitzsch
Boehringer Ingelheim Investigational Site
Demen
Boehringer Ingelheim Investigational Site
Denkendorf
Boehringer Ingelheim Investigational Site
Dessau
Boehringer Ingelheim Investigational Site
Detmold
Boehringer Ingelheim Investigational Site
Dettenheim
Boehringer Ingelheim Investigational Site
Deuben
Boehringer Ingelheim Investigational Site
Deutzen
Boehringer Ingelheim Investigational Site
Diepholz
Boehringer Ingelheim Investigational Site
Dillingen
Boehringer Ingelheim Investigational Site
Dingolfing
Boehringer Ingelheim Investigational Site
Dinkelsbühl
Boehringer Ingelheim Investigational Site
Dinslaken
Boehringer Ingelheim Investigational Site
Dissen
Boehringer Ingelheim Investigational Site
Dogern
Boehringer Ingelheim Investigational Site
Dollern
Boehringer Ingelheim Investigational Site
Donaueschingen
Boehringer Ingelheim Investigational Site
Dörentrup
Boehringer Ingelheim Investigational Site
Dormagen
Boehringer Ingelheim Investigational Site
Dornstetten
Boehringer Ingelheim Investigational Site
Dörpen
Boehringer Ingelheim Investigational Site
Dorsten
Boehringer Ingelheim Investigational Site
Dortmund
Boehringer Ingelheim Investigational Site
Dreieich
Boehringer Ingelheim Investigational Site
Drensteinfurt
Boehringer Ingelheim Investigational Site
Dresden
Boehringer Ingelheim Investigational Site
Driedorf
Boehringer Ingelheim Investigational Site
Duderstadt
Boehringer Ingelheim Investigational Site
Duisburg
Boehringer Ingelheim Investigational Site
Dummerstorf
Boehringer Ingelheim Investigational Site
Düren
Boehringer Ingelheim Investigational Site
Düsseldorf
Boehringer Ingelheim Investigational Site
Ebergötzen
Boehringer Ingelheim Investigational Site
Ebermannstadt
Boehringer Ingelheim Investigational Site
Eberstadt
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Ebhausen
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Edewecht
Boehringer Ingelheim Investigational Site
Edling
Boehringer Ingelheim Investigational Site
Egelsbach
Boehringer Ingelheim Investigational Site
Ehingen
Boehringer Ingelheim Investigational Site
Eilenburg
Boehringer Ingelheim Investigational Site
Eisenhüttenstadt
Boehringer Ingelheim Investigational Site
Eiterfeld
Boehringer Ingelheim Investigational Site
Eitorf
Boehringer Ingelheim Investigational Site
Ellwangen
Boehringer Ingelheim Investigational Site
Elmshorn
Boehringer Ingelheim Investigational Site
Emersacker
Boehringer Ingelheim Investigational Site
Emmendingen
Boehringer Ingelheim Investigational Site
Emsdetten
Boehringer Ingelheim Investigational Site
Enger
Boehringer Ingelheim Investigational Site
Enkenbach-Alsenborn
Boehringer Ingelheim Investigational Site
Ennepetal
Boehringer Ingelheim Investigational Site
Ennigerloh
Boehringer Ingelheim Investigational Site
Eppstein
Boehringer Ingelheim Investigational Site
Erding
Boehringer Ingelheim Investigational Site
Erftstadt
Boehringer Ingelheim Investigational Site
Erkrath
Boehringer Ingelheim Investigational Site
Erligheim
Boehringer Ingelheim Investigational Site
Erndtebrück
Boehringer Ingelheim Investigational Site
Erolzheim
Boehringer Ingelheim Investigational Site
Eschborn
Boehringer Ingelheim Investigational Site
Eschelbronn
Boehringer Ingelheim Investigational Site
Eschweiler
Boehringer Ingelheim Investigational Site
Eslohe
Boehringer Ingelheim Investigational Site
Espenhain
Boehringer Ingelheim Investigational Site
Essen
Boehringer Ingelheim Investigational Site
Esslingen am Neckar
Boehringer Ingelheim Investigational Site
Euskirchen
Boehringer Ingelheim Investigational Site
Filderstadt
Boehringer Ingelheim Investigational Site
Floh-Seligenthal
Boehringer Ingelheim Investigational Site
Flöha
Boehringer Ingelheim Investigational Site
Forbach
Boehringer Ingelheim Investigational Site
Forchheim
Boehringer Ingelheim Investigational Site
Frankenberg
Boehringer Ingelheim Investigational Site
Frankenthal
Boehringer Ingelheim Investigational Site
Frankfurt
Boehringer Ingelheim Investigational Site
Freiberg
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site
Freigericht
Boehringer Ingelheim Investigational Site
Freudenstadt
Boehringer Ingelheim Investigational Site
Freyung
Boehringer Ingelheim Investigational Site
Friedland
Boehringer Ingelheim Investigational Site
Friedrichshafen
Boehringer Ingelheim Investigational Site
Friedrichsthal
Boehringer Ingelheim Investigational Site
Frohburg
Boehringer Ingelheim Investigational Site
Fulda
Boehringer Ingelheim Investigational Site
Fürstenwalde
Boehringer Ingelheim Investigational Site
Furtwangen im Schwarzwald
Boehringer Ingelheim Investigational Site
Füssen
Boehringer Ingelheim Investigational Site
Gangelt
Boehringer Ingelheim Investigational Site
Gardelegen
Boehringer Ingelheim Investigational Site
Garmisch-Partenkirchen
Boehringer Ingelheim Investigational Site
Gars
Boehringer Ingelheim Investigational Site
Gebesee
Boehringer Ingelheim Investigational Site
Geesthacht
Boehringer Ingelheim Investigational Site
Gelbensande
Boehringer Ingelheim Investigational Site
Gelsenkirchen
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Gensingen
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Georgsmarienhütte
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Gera
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Gerbstedt
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Germering
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Germersheim
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Gevelsberg
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Giessen
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Gifhorn
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Gilserberg
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Gladbeck
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Gleichen
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Goch
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Gochsheim
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Göllheim
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Göllingen
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Gomaringen
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Göttingen
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Grafenau
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Gransee
Boehringer Ingelheim Investigational Site
Grassau
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Greiz
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Greven
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Grevesmühlen
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Griesheim
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Grömitz
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Gronau
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Groß Grönau
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Groß Quenstedt
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Groß-Zimmern
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Großalmerode
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Großbottwar
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Großefehn
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Großhabersdorf
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Großkorbetha
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Großlangheim
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Grünbach
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Gummersbach
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Güstrow
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Haag
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Hagen
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Haigerloch
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Haldensleben I
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Halle
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Hamburg
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Hamm
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Hamminkeln
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Hanau
Boehringer Ingelheim Investigational Site
Hanerau-Hademarschen
Boehringer Ingelheim Investigational Site
Hanover

Other trials in Germany

About this study

Official title: Sifrol® (Pramipexole) Impact on RLS Related Quality of Life: A 12-weeks Observational Study in Patients With Primary RLS

In this German non-interventional observational study 1980 patients diagnosed with Restless Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal states in Germany. Both moderate to severe RLS patients, with or without previous RLS treatment, suffering from RLS symptoms like a desire to move the extremities usually associated with some discomfort, motor restlessness and worsening of symptoms at rest with at least temporary relief by activity, worsening of symptoms later in the day or at night, are eligible for this study, if it is planned to initiate therapy with pramipexole or to add pramipexole to a previously given, insufficient therapy. Three visits are planned to be documented in this PMS study, one baseline visit, visit two after the end of pramipexole titration and visit three after 12 weeks of treatment. Evaluations and visits are to be carried out and documented only if part of routine medical practice. The main goal of observational studies is to determine how pramipexole treatment works when applied in actual practice and thus maximise external validity. In actual practice patients who have been excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will be treated with PPX. Thus in addition during this observational study information on the efficacy and safety of PPX in those patients will be obtained. The objectives of this PMS study are:

To evaluate the treatment effect of pramipexole on RLS severity and general improvement as measured by IRLS and CGI-I.
To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome Quality of Life questionnaire (RLS-QoL).
To evaluate the safety profile of PPX in a natural study population.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in IRLS total score after 12 weeks
Measured: 12 weeks
CGI-I responder rate after 12 weeks
Measured: 12 weeks
Time to reach maintenance dose
Measured: 12 weeks
Change from baseline in RLS-QoL total score after 12 weeks
Measured: 12 weeks

Secondary outcomes (5)

Change from baseline in IRLS score after 1-4 weeks
Measured: 4 weeks
Change in IRLS items after 12 weeks
Measured: 12 weeks
Final dose distribution
Measured: 12 weeks
Incidence, relationship and seriousness of adverse events
Measured: 12 weeks
Number of premature discontinuations
Measured: 12 weeks

Timeline

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

Feb 2007Nov 2007

First posted4 Oct 2007 (estimated)
Study startFeb 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
Time perspective: Prospective
Enrolment: 2,023 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00539461
Sponsor's protocol ID: 248.638
Status last verified: Oct 2013
First submitted: 28 Sep 2007
Last updated: 1 Nov 2013
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 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sifrol® (Pramipexole) Impact on RLS Related Quality of Life: A 12-weeks Observational Study in Patients With Primary RLS
ClinicalTrials.gov ID: NCT00539461
Acronym / sponsor ID: 248.638
Conditions: Restless Legs Syndrome
Study type: Observational
Recruitment status: Completed
Enrolment: 2,023 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Nov 2007 (actual)
First posted: 4 Oct 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.

To evaluate the treatment effect of pramipexole on RLS severity and general improvement as measured by IRLS and CGI-I.
To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome Quality of Life questionnaire (RLS-QoL).
To evaluate the safety profile of PPX in a natural study population.

Study design

Time perspective: Prospective

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosis of primary RLS
Indication for RLS treatment with Sifrol® (pramipexole)
Male or female patients aged at least 18 years.

Key exclusion criteria (2 listed)

Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
Ongoing treatment with Sifrol® (pramipexole).

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

Change from baseline in IRLS total score after 12 weeks
Time frame: 12 weeks
CGI-I responder rate after 12 weeks
Time frame: 12 weeks
Time to reach maintenance dose
Time frame: 12 weeks
Change from baseline in RLS-QoL total score after 12 weeks
Time frame: 12 weeks

5 secondary outcomes

Change from baseline in IRLS score after 1-4 weeks
Time frame: 4 weeks
Change in IRLS items after 12 weeks
Time frame: 12 weeks
Final dose distribution
Time frame: 12 weeks
Incidence, relationship and seriousness of adverse events
Time frame: 12 weeks
Number of premature discontinuations
Time frame: 12 weeks

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 1 Nov 2013.

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.

The record lists no contact. Use the official record to reach the sponsor.

317 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 317 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 3 inclusion and 2 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 317 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.

What does the primary outcome measure?

Change from baseline in IRLS total score after 12 weeks (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00539461.

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 1 Nov 2013.