Restless Legs SyndromeNCT00887289

Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 784 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: 1,504 participants
Where: 784 sitesGermany
Study dates: Apr 2009to Oct 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 moderate to severe Restless Legs Syndrome.
Patients who are planned to be treated with Sifrol® (pramipexole) and where the decision of treatment is made independent of the patients' inclusion into this post marketing surveillance study.
Male or female patients aged at least 18 years.
Written informed consent by the patient for study participation.

Who cannot join

Any contraindications according to the Summary of Product Characteristics: hypersensitivity to pramipexole or to any of the excipients.
Previous or ongoing treatment with Sifrol® (pramipexole).
Previous or ongoing treatment with dopamine receptor agonists.

Trial locations and contacts

784 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Germany300 sites

Boehringer Ingelheim Investigational Site
Aalen
Boehringer Ingelheim Investigational Site 1
Achim
Boehringer Ingelheim Investigational Site 2
Achim
Boehringer Ingelheim Investigational Site 1
Ahrensburg
Boehringer Ingelheim Investigational Site 2
Ahrensburg
Boehringer Ingelheim Investigational Site
Albstadt
Boehringer Ingelheim Investigational Site
Alfeld
Boehringer Ingelheim Investigational Site
Allendorf
Boehringer Ingelheim Investigational Site 1
Alzenau in Unterfranken
Boehringer Ingelheim Investigational Site 2
Alzenau in Unterfranken
Boehringer Ingelheim Investigational Site
Anklam
Boehringer Ingelheim Investigational Site
Annaberg-Buchholz
Boehringer Ingelheim Investigational Site
Ansbach
Boehringer Ingelheim Investigational Site
Apolda
Boehringer Ingelheim Investigational Site
Arenshausen
Boehringer Ingelheim Investigational Site 1
Arnsberg
Boehringer Ingelheim Investigational Site 2
Arnsberg
Boehringer Ingelheim Investigational Site
Asperg
Boehringer Ingelheim Investigational Site 1
Attendorn
Boehringer Ingelheim Investigational Site 2
Attendorn
Boehringer Ingelheim Investigational Site
Aue
Boehringer Ingelheim Investigational Site 1
Augsburg
Boehringer Ingelheim Investigational Site 2
Augsburg
Boehringer Ingelheim Investigational Site 3
Augsburg
Boehringer Ingelheim Investigational Site
Aurich
Boehringer Ingelheim Investigational Site
Backnang
Boehringer Ingelheim Investigational Site
Bad Arolsen
Boehringer Ingelheim Investigational Site
Bad Bevensen
Boehringer Ingelheim Investigational Site
Bad Ems
Boehringer Ingelheim Investigational Site 1
Bad Hersfeld
Boehringer Ingelheim Investigational Site 2
Bad Hersfeld
Boehringer Ingelheim Investigational Site 1
Bad Honnef
Boehringer Ingelheim Investigational Site 2
Bad Honnef
Boehringer Ingelheim Investigational Site
Bad Krozingen
Boehringer Ingelheim Investigational Site
Bad Laer
Boehringer Ingelheim Investigational Site
Bad Lausick
Boehringer Ingelheim Investigational Site
Bad Marienberg
Boehringer Ingelheim Investigational Site 1
Bad Neuenahr-Ahrweiler
Boehringer Ingelheim Investigational Site 2
Bad Neuenahr-Ahrweiler
Boehringer Ingelheim Investigational Site
Bad Neustadt an der Saale
Boehringer Ingelheim Investigational Site
Bad Reichenhall
Boehringer Ingelheim Investigational Site
Bad Sachsa
Boehringer Ingelheim Investigational Site
Bad Salzuflen
Boehringer Ingelheim Investigational Site 1
Bad Salzungen
Boehringer Ingelheim Investigational Site 2
Bad Salzungen
Boehringer Ingelheim Investigational Site 3
Bad Salzungen
Boehringer Ingelheim Investigational Site
Bad Schwartau
Boehringer Ingelheim Investigational Site 1
Bad Segeberg
Boehringer Ingelheim Investigational Site 2
Bad Segeberg
Boehringer Ingelheim Investigational Site
Bad Sooden-Allendorf
Boehringer Ingelheim Investigational Site
Bad Tennstedt
Boehringer Ingelheim Investigational Site
Bad Wörishofen
Boehringer Ingelheim Investigational Site
Baden-Baden
Boehringer Ingelheim Investigational Site
Baesweiler
Boehringer Ingelheim Investigational Site 1
Bamberg
Boehringer Ingelheim Investigational Site 2
Bamberg
Boehringer Ingelheim Investigational Site 3
Bamberg
Boehringer Ingelheim Investigational Site
Baunatal
Boehringer Ingelheim Investigational Site
Bautzen
Boehringer Ingelheim Investigational Site 1
Bayreuth
Boehringer Ingelheim Investigational Site 2
Bayreuth
Boehringer Ingelheim Investigational Site
Bergheim
Boehringer Ingelheim Investigational Site 1
Bergkamen
Boehringer Ingelheim Investigational Site 2
Bergkamen
Boehringer Ingelheim Investigational Site 10
Berlin
Boehringer Ingelheim Investigational Site 11
Berlin
Boehringer Ingelheim Investigational Site 12
Berlin
Boehringer Ingelheim Investigational Site 13
Berlin
Boehringer Ingelheim Investigational Site 14
Berlin
Boehringer Ingelheim Investigational Site 15
Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
Boehringer Ingelheim Investigational Site 20
Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
Boehringer Ingelheim Investigational Site 9
Berlin
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Biberach
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Bielefeld
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Bingen
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Bissendorf
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Bitterfeld-Wolfen
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Blankenhagen
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Blaustein
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Blieskastel
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Bochum
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Bochum
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Bochum
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Bochum
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Bochum
Boehringer Ingelheim Investigational Site 6
Bochum
Boehringer Ingelheim Investigational Site 7
Bochum
Boehringer Ingelheim Investigational Site 1
Bockhorn
Boehringer Ingelheim Investigational Site 2
Bockhorn
Boehringer Ingelheim Investigational Site 1
Bodelshausen
Boehringer Ingelheim Investigational Site 2
Bodelshausen
Boehringer Ingelheim Investigational Site 1
Bonn
Boehringer Ingelheim Investigational Site 2
Bonn
Boehringer Ingelheim Investigational Site
Bordesholm
Boehringer Ingelheim Investigational Site
Bottrop
Boehringer Ingelheim Investigational Site
Braunschweig
Boehringer Ingelheim Investigational Site 1
Bremen
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Bremen
Boehringer Ingelheim Investigational Site 3
Bremen
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Bremerhaven
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Bremerhaven
Boehringer Ingelheim Investigational Site 3
Bremerhaven
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Breuberg
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Bruchsal
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Brühl
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Buchbach
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Büchen
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Bückeburg
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Burgdorf, Hanover
Boehringer Ingelheim Investigational Site
Burglengenfeld
Boehringer Ingelheim Investigational Site
Burscheid
Boehringer Ingelheim Investigational Site 1
Butzbach
Boehringer Ingelheim Investigational Site 2
Butzbach
Boehringer Ingelheim Investigational Site
Buxtehude
Boehringer Ingelheim Investigational Site
Calw
Boehringer Ingelheim Investigational Site 1
Celle
Boehringer Ingelheim Investigational Site 2
Celle
Boehringer Ingelheim Investigational Site 1
Chemnitz
Boehringer Ingelheim Investigational Site 2
Chemnitz
Boehringer Ingelheim Investigational Site 3
Chemnitz
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Chemnitz
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Chemnitz
Boehringer Ingelheim Investigational Site
Coburg
Boehringer Ingelheim Investigational Site
Coesfeld
Boehringer Ingelheim Investigational Site 1
Cologne
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Cologne
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Cologne
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Cologne
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Cologne
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Cologne
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Cologne
Boehringer Ingelheim Investigational Site 8
Cologne
Boehringer Ingelheim Investigational Site 9
Cologne
Boehringer Ingelheim Investigational Site
Cottbus
Boehringer Ingelheim Investigational Site 1
Crimmitschau
Boehringer Ingelheim Investigational Site 2
Crimmitschau
Boehringer Ingelheim Investigational Site
Dachau
Boehringer Ingelheim Investigational Site
Delbrück
Boehringer Ingelheim Investigational Site
Delmenhorst
Boehringer Ingelheim Investigational Site
Dernau
Boehringer Ingelheim Investigational Site 1
Dessau
Boehringer Ingelheim Investigational Site 2
Dessau
Boehringer Ingelheim Investigational Site 3
Dessau
Boehringer Ingelheim Investigational Site 4
Dessau
Boehringer Ingelheim Investigational Site 1
Dietzenbach
Boehringer Ingelheim Investigational Site 2
Dietzenbach
Boehringer Ingelheim Investigational Site 3
Dietzenbach
Boehringer Ingelheim Investigational Site
Dillingen
Boehringer Ingelheim Investigational Site
Dinkelsbühl
Boehringer Ingelheim Investigational Site 1
Dippoldiswalde
Boehringer Ingelheim Investigational Site 2
Dippoldiswalde
Boehringer Ingelheim Investigational Site
Döbeln
Boehringer Ingelheim Investigational Site 1
Dörentrup
Boehringer Ingelheim Investigational Site 2
Dörentrup
Boehringer Ingelheim Investigational Site 1
Dortmund
Boehringer Ingelheim Investigational Site 2
Dortmund
Boehringer Ingelheim Investigational Site 3
Dortmund
Boehringer Ingelheim Investigational Site 4
Dortmund
Boehringer Ingelheim Investigational Site 1
Dresden
Boehringer Ingelheim Investigational Site 2
Dresden
Boehringer Ingelheim Investigational Site 3
Dresden
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Driedorf
Boehringer Ingelheim Investigational Site
Duderstadt
Boehringer Ingelheim Investigational Site 1
Duisburg
Boehringer Ingelheim Investigational Site 2
Duisburg
Boehringer Ingelheim Investigational Site 3
Duisburg
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Durmersheim
Boehringer Ingelheim Investigational Site 1
Düsseldorf
Boehringer Ingelheim Investigational Site 2
Düsseldorf
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Düsseldorf
Boehringer Ingelheim Investigational Site 4
Düsseldorf
Boehringer Ingelheim Investigational Site 5
Düsseldorf
Boehringer Ingelheim Investigational Site 6
Düsseldorf
Boehringer Ingelheim Investigational Site 7
Düsseldorf
Boehringer Ingelheim Investigational Site 8
Düsseldorf
Boehringer Ingelheim Investigational Site 9
Düsseldorf
Boehringer Ingelheim Investigational Site
Ebermannstadt
Boehringer Ingelheim Investigational Site 1
Edingen-Neckarhausen
Boehringer Ingelheim Investigational Site 2
Edingen-Neckarhausen
Boehringer Ingelheim Investigational Site
Edling
Boehringer Ingelheim Investigational Site
Eilenburg
Boehringer Ingelheim Investigational Site 1
Eisenach
Boehringer Ingelheim Investigational Site 2
Eisenach
Boehringer Ingelheim Investigational Site
Eisenberg
Boehringer Ingelheim Investigational Site
Eisenhüttenstadt
Boehringer Ingelheim Investigational Site
Ellwangen
Boehringer Ingelheim Investigational Site
Emmendingen
Boehringer Ingelheim Investigational Site
Emsdetten
Boehringer Ingelheim Investigational Site
Emskirchen
Boehringer Ingelheim Investigational Site
Enkirch
Boehringer Ingelheim Investigational Site
Ennigerloh
Boehringer Ingelheim Investigational Site
Eppelheim
Boehringer Ingelheim Investigational Site 1
Erbach im Odenwald
Boehringer Ingelheim Investigational Site 2
Erbach im Odenwald
Boehringer Ingelheim Investigational Site 3
Erbach im Odenwald
Boehringer Ingelheim Investigational Site 1
Erfurt
Boehringer Ingelheim Investigational Site 2
Erfurt
Boehringer Ingelheim Investigational Site 3
Erfurt
Boehringer Ingelheim Investigational Site
Erkrath
Boehringer Ingelheim Investigational Site 1
Erlangen
Boehringer Ingelheim Investigational Site
Eschborn
Boehringer Ingelheim Investigational Site
Eschlkam
Boehringer Ingelheim Investigational Site 10
Essen
Boehringer Ingelheim Investigational Site 11
Essen
Boehringer Ingelheim Investigational Site 12
Essen
Boehringer Ingelheim Investigational Site 13
Essen
Boehringer Ingelheim Investigational Site 14
Essen
Boehringer Ingelheim Investigational Site 1
Essen
Boehringer Ingelheim Investigational Site 2
Essen
Boehringer Ingelheim Investigational Site 3
Essen
Boehringer Ingelheim Investigational Site 4
Essen
Boehringer Ingelheim Investigational Site 5
Essen
Boehringer Ingelheim Investigational Site 6
Essen
Boehringer Ingelheim Investigational Site 7
Essen
Boehringer Ingelheim Investigational Site 8
Essen
Boehringer Ingelheim Investigational Site 9
Essen
Boehringer Ingelheim Investigational Site
Ettlingen
Boehringer Ingelheim Investigational Site
Extertal
Boehringer Ingelheim Investigational Site
Falkenhagen
Boehringer Ingelheim Investigational Site
Fehrbellin
Boehringer Ingelheim Investigational Site
Flintbek
Boehringer Ingelheim Investigational Site 1
Frankfurt
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Frankfurt
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Frankfurt
Boehringer Ingelheim Investigational Site
Freiberg
Boehringer Ingelheim Investigational Site 1
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 2
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 3
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 4
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 5
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site
Freilassing
Boehringer Ingelheim Investigational Site
Freinsheim
Boehringer Ingelheim Investigational Site 1
Freital
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Freital
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Freital
Boehringer Ingelheim Investigational Site
Friedrichshafen
Boehringer Ingelheim Investigational Site 1
Friedrichsthal
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Friedrichsthal
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Fulda
Boehringer Ingelheim Investigational Site
Fürstenfeldbruck
Boehringer Ingelheim Investigational Site 1
Fürstenwalde
Boehringer Ingelheim Investigational Site 2
Fürstenwalde
Boehringer Ingelheim Investigational Site
Fürstenzell
Boehringer Ingelheim Investigational Site 1
Fürth
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Fürth
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Gauting
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Geisenhausen
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Geithain
Boehringer Ingelheim Investigational Site 1
Gelnhausen
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Gelnhausen
Boehringer Ingelheim Investigational Site 1
Gelsenkirchen
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Gelsenkirchen
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Gelsenkirchen
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Gelsenkirchen
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Gera
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Gerbstedt
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Germering
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Gersthofen
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Giengen an der Brenz
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Gladbeck
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Gladenbach
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Glauchau
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Gleichen
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Glienicke
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Glücksburg
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Göppingen
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Gosheim
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Gößweinstein
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Göttingen
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Göttingen
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Göttingen
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Göttingen
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Göttingen
Boehringer Ingelheim Investigational Site
Greifswald
Boehringer Ingelheim Investigational Site
Greven

Other trials in Germany

About this study

Official title: Non-interventional Observational Study on the Influence of Pramipexole (PPX) on Sensory Symptoms of Restless Legs Syndrome (RLS)

The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with pramipexole. Thus, during this post marketing surveillance study additional information on the efficacy and safety of pramipexole in those patients will be obtained. The objectives of this post marketing surveillance study are:

To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain Questionnaire.
To assess if improvement of sensory symptoms correlates with overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 \& 6 from Restless Legs Syndrome-6).
To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) differs between patients with high pain scores and patients with lower pain scores.
To compare General Practitioner and neurologist sites patient populations in terms of demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit 3.
To evaluate the development of behavioural changes under pramipexole treatment.

Read the detailed description

Study Design:

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.

Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Measured: Baseline to Visit 3
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Measured: Baseline to Visit 3
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Measured: Baseline to Visit 3

Secondary outcomes (3)

Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3
Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.
Measured: Baseline to Visit 3
Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3
Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.
Measured: Baseline to Visit 3
Behavioural Changes During Treatment
Number of patients with occurence of behavioural changes in terms of impulse control disorders
Measured: Baseline to Visit 3

Timeline

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

Apr 2009Oct 2009

First posted23 Apr 2009 (estimated)
Study startApr 2009
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 1,504 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00887289
Sponsor's protocol ID: 248.659
Status last verified: Mar 2014
First submitted: 29 Jul 2008
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

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

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All Restless Legs Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Observational Study on the Influence of Pramipexole (PPX) on Sensory Symptoms of Restless Legs Syndrome (RLS)
ClinicalTrials.gov ID: NCT00887289
Acronym / sponsor ID: 248.659
Conditions: Restless Legs Syndrome
Study type: Observational
Recruitment status: Completed
Enrolment: 1,504 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 23 Apr 2009 (estimated)
Results: Posted 15 Dec 2010

Clinical summary

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

To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain Questionnaire.
To assess if improvement of sensory symptoms correlates with overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 \& 6 from Restless Legs Syndrome-6).
To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) differs between patients with high pain scores and patients with lower pain scores.
To compare General Practitioner and neurologist sites patient populations in terms of demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit 3.
To evaluate the development of behavioural changes under pramipexole treatment.

Detailed description

Study Design:

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 (4 listed)

Diagnosis of primary moderate to severe Restless Legs Syndrome.
Patients who are planned to be treated with Sifrol® (pramipexole) and where the decision of treatment is made independent of the patients' inclusion into this post marketing surveillance study.
Male or female patients aged at least 18 years.
Written informed consent by the patient for study participation.

Key exclusion criteria (3 listed)

Any contraindications according to the Summary of Product Characteristics: hypersensitivity to pramipexole or to any of the excipients.
Previous or ongoing treatment with Sifrol® (pramipexole).
Previous or ongoing treatment with dopamine receptor agonists.

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

Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3
Time frame: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner
Time frame: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist
Time frame: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.

3 secondary outcomes

Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3
Time frame: Baseline to Visit 3
Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3
Time frame: Baseline to Visit 3
Behavioural Changes During Treatment
Time frame: Baseline to Visit 3

Results and safety

Results posted to the registry on 15 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pramipexole	1,504	1,409

Primary outcome: Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3

Time frame: Baseline to Visit 3. Mean (Standard Deviation). Unit: Scores on scale

Measure	Pramipexole n = 1320
Value	-14.48 (9.69)

Population analysed: Full analysis set, no imputation technique was applied

Primary outcome: Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner

Time frame: Baseline to Visit 3. Mean (Standard Deviation). Unit: Scores on scale

Measure	Pramipexole n = 830
Value	-15.87 (9.39)

Population analysed: All patients of the full analysis set treated by a general practitioner, no imputation technique was applied

Primary outcome: Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist

Time frame: Baseline to Visit 3. Mean (Standard Deviation). Unit: Scores on scale

Measure	Pramipexole n = 490
Value	-12.13 (9.73)

Population analysed: All patients of the full analysis set treated by a neurologist, no imputation technique was applied

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pramipexole	6 of 1,504 (0.4%)	0 of 1,504 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

784 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 784 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 4 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 784 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?

Yes. Results are posted in the registry (first posted 15 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 (time frame: Baseline to Visit 3). The study lists 3 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 NCT00887289.

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 27 Jun 2014.