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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00887289
Other study ID # 248.659
Secondary ID
Status Completed
Phase N/A
First received July 29, 2008
Last updated June 17, 2014
Start date April 2009
Est. completion date October 2009

Study information

Verified date March 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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.


Description:

Study Design:


Recruitment information / eligibility

Status Completed
Enrollment 1504
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

1. Diagnosis of primary moderate to severe Restless Legs Syndrome.

2. Patients who are planned to be treated with SifrolĀ® (pramipexole) and where the decision of treatment is made independent of the patients' inclusion into this post marketing surveillance study.

3. Male or female patients aged at least 18 years.

4. Written informed consent by the patient for study participation.

Exclusion criteria:

1. Any contraindications according to the Summary of Product Characteristics: hypersensitivity to pramipexole or to any of the excipients.

2. Previous or ongoing treatment with SifrolĀ® (pramipexole).

3. Previous or ongoing treatment with dopamine receptor agonists.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Boehringer Ingelheim Investigational Site Aalen
Germany Boehringer Ingelheim Investigational Site 1 Achim
Germany Boehringer Ingelheim Investigational Site 2 Achim
Germany Boehringer Ingelheim Investigational Site 1 Ahrensburg
Germany Boehringer Ingelheim Investigational Site 2 Ahrensburg
Germany Boehringer Ingelheim Investigational Site Albstadt
Germany Boehringer Ingelheim Investigational Site Alfeld
Germany Boehringer Ingelheim Investigational Site Allendorf
Germany Boehringer Ingelheim Investigational Site 1 Alzenau
Germany Boehringer Ingelheim Investigational Site 2 Alzenau
Germany Boehringer Ingelheim Investigational Site Anklam
Germany Boehringer Ingelheim Investigational Site Annaberg-Buchholz
Germany Boehringer Ingelheim Investigational Site Ansbach
Germany Boehringer Ingelheim Investigational Site Apolda
Germany Boehringer Ingelheim Investigational Site Arenshausen
Germany Boehringer Ingelheim Investigational Site 1 Arnsberg
Germany Boehringer Ingelheim Investigational Site 2 Arnsberg
Germany Boehringer Ingelheim Investigational Site Asperg
Germany Boehringer Ingelheim Investigational Site 1 Attendorn
Germany Boehringer Ingelheim Investigational Site 2 Attendorn
Germany Boehringer Ingelheim Investigational Site Aue
Germany Boehringer Ingelheim Investigational Site 1 Augsburg
Germany Boehringer Ingelheim Investigational Site 2 Augsburg
Germany Boehringer Ingelheim Investigational Site 3 Augsburg
Germany Boehringer Ingelheim Investigational Site Aurich
Germany Boehringer Ingelheim Investigational Site Backnang
Germany Boehringer Ingelheim Investigational Site Bad Arolsen
Germany Boehringer Ingelheim Investigational Site Bad Bevensen
Germany Boehringer Ingelheim Investigational Site Bad Ems
Germany Boehringer Ingelheim Investigational Site 1 Bad Hersfeld
Germany Boehringer Ingelheim Investigational Site 2 Bad Hersfeld
Germany Boehringer Ingelheim Investigational Site 1 Bad Honnef
Germany Boehringer Ingelheim Investigational Site 2 Bad Honnef
Germany Boehringer Ingelheim Investigational Site Bad Krozingen
Germany Boehringer Ingelheim Investigational Site Bad Laer
Germany Boehringer Ingelheim Investigational Site Bad Lausick
Germany Boehringer Ingelheim Investigational Site Bad Marienberg
Germany Boehringer Ingelheim Investigational Site 1 Bad Neuenahr-Ahrweiler
Germany Boehringer Ingelheim Investigational Site 2 Bad Neuenahr-Ahrweiler
Germany Boehringer Ingelheim Investigational Site Bad Neustadt
Germany Boehringer Ingelheim Investigational Site Bad Reichenhall
Germany Boehringer Ingelheim Investigational Site Bad Sachsa
Germany Boehringer Ingelheim Investigational Site Bad Salzuflen
Germany Boehringer Ingelheim Investigational Site 1 Bad Salzungen
Germany Boehringer Ingelheim Investigational Site 2 Bad Salzungen
Germany Boehringer Ingelheim Investigational Site 3 Bad Salzungen
Germany Boehringer Ingelheim Investigational Site Bad Schwartau
Germany Boehringer Ingelheim Investigational Site 1 Bad Segeberg
Germany Boehringer Ingelheim Investigational Site 2 Bad Segeberg
Germany Boehringer Ingelheim Investigational Site Bad Sooden-Allendorf
Germany Boehringer Ingelheim Investigational Site Bad Tennstedt
Germany Boehringer Ingelheim Investigational Site Bad Wörishofen
Germany Boehringer Ingelheim Investigational Site Baden-Baden
Germany Boehringer Ingelheim Investigational Site Baesweiler
Germany Boehringer Ingelheim Investigational Site 1 Bamberg
Germany Boehringer Ingelheim Investigational Site 2 Bamberg
Germany Boehringer Ingelheim Investigational Site 3 Bamberg
Germany Boehringer Ingelheim Investigational Site Baunatal
Germany Boehringer Ingelheim Investigational Site Bautzen
Germany Boehringer Ingelheim Investigational Site 1 Bayreuth
Germany Boehringer Ingelheim Investigational Site 2 Bayreuth
Germany Boehringer Ingelheim Investigational Site Bergheim
Germany Boehringer Ingelheim Investigational Site 1 Bergkamen
Germany Boehringer Ingelheim Investigational Site 2 Bergkamen
Germany Boehringer Ingelheim Investigational Site 1 Berlin
Germany Boehringer Ingelheim Investigational Site 10 Berlin
Germany Boehringer Ingelheim Investigational Site 11 Berlin
Germany Boehringer Ingelheim Investigational Site 12 Berlin
Germany Boehringer Ingelheim Investigational Site 13 Berlin
Germany Boehringer Ingelheim Investigational Site 14 Berlin
Germany Boehringer Ingelheim Investigational Site 15 Berlin
Germany Boehringer Ingelheim Investigational Site 16 Berlin
Germany Boehringer Ingelheim Investigational Site 17 Berlin
Germany Boehringer Ingelheim Investigational Site 18 Berlin
Germany Boehringer Ingelheim Investigational Site 19 Berlin
Germany Boehringer Ingelheim Investigational Site 2 Berlin
Germany Boehringer Ingelheim Investigational Site 20 Berlin
Germany Boehringer Ingelheim Investigational Site 21 Berlin
Germany Boehringer Ingelheim Investigational Site 22 Berlin
Germany Boehringer Ingelheim Investigational Site 23 Berlin
Germany Boehringer Ingelheim Investigational Site 24 Berlin
Germany Boehringer Ingelheim Investigational Site 25 Berlin
Germany Boehringer Ingelheim Investigational Site 26 Berlin
Germany Boehringer Ingelheim Investigational Site 27 Berlin
Germany Boehringer Ingelheim Investigational Site 28 Berlin
Germany Boehringer Ingelheim Investigational Site 29 Berlin
Germany Boehringer Ingelheim Investigational Site 3 Berlin
Germany Boehringer Ingelheim Investigational Site 30 Berlin
Germany Boehringer Ingelheim Investigational Site 31 Berlin
Germany Boehringer Ingelheim Investigational Site 32 Berlin
Germany Boehringer Ingelheim Investigational Site 33 Berlin
Germany Boehringer Ingelheim Investigational Site 4 Berlin
Germany Boehringer Ingelheim Investigational Site 5 Berlin
Germany Boehringer Ingelheim Investigational Site 6 Berlin
Germany Boehringer Ingelheim Investigational Site 7 Berlin
Germany Boehringer Ingelheim Investigational Site 8 Berlin
Germany Boehringer Ingelheim Investigational Site 9 Berlin
Germany Boehringer Ingelheim Investigational Site Biberach
Germany Boehringer Ingelheim Investigational Site Bielefeld
Germany Boehringer Ingelheim Investigational Site Bingen
Germany Boehringer Ingelheim Investigational Site Bissendorf
Germany Boehringer Ingelheim Investigational Site Bitterfeld
Germany Boehringer Ingelheim Investigational Site Blankenhagen
Germany Boehringer Ingelheim Investigational Site Blaustein
Germany Boehringer Ingelheim Investigational Site Blieskastel
Germany Boehringer Ingelheim Investigational Site 1 Bochum
Germany Boehringer Ingelheim Investigational Site 2 Bochum
Germany Boehringer Ingelheim Investigational Site 3 Bochum
Germany Boehringer Ingelheim Investigational Site 4 Bochum
Germany Boehringer Ingelheim Investigational Site 5 Bochum
Germany Boehringer Ingelheim Investigational Site 6 Bochum
Germany Boehringer Ingelheim Investigational Site 7 Bochum
Germany Boehringer Ingelheim Investigational Site 1 Bockhorn
Germany Boehringer Ingelheim Investigational Site 2 Bockhorn
Germany Boehringer Ingelheim Investigational Site 1 Bodelshausen
Germany Boehringer Ingelheim Investigational Site 2 Bodelshausen
Germany Boehringer Ingelheim Investigational Site 1 Bonn
Germany Boehringer Ingelheim Investigational Site 2 Bonn
Germany Boehringer Ingelheim Investigational Site Bordesholm
Germany Boehringer Ingelheim Investigational Site Bottrop
Germany Boehringer Ingelheim Investigational Site Braunschweig
Germany Boehringer Ingelheim Investigational Site 1 Bremen
Germany Boehringer Ingelheim Investigational Site 2 Bremen
Germany Boehringer Ingelheim Investigational Site 3 Bremen
Germany Boehringer Ingelheim Investigational Site 1 Bremerhaven
Germany Boehringer Ingelheim Investigational Site 2 Bremerhaven
Germany Boehringer Ingelheim Investigational Site 3 Bremerhaven
Germany Boehringer Ingelheim Investigational Site Breuberg
Germany Boehringer Ingelheim Investigational Site Bruchsal
Germany Boehringer Ingelheim Investigational Site Brühl
Germany Boehringer Ingelheim Investigational Site Buchbach
Germany Boehringer Ingelheim Investigational Site Buchen
Germany Boehringer Ingelheim Investigational Site Büchen
Germany Boehringer Ingelheim Investigational Site Bückeburg
Germany Boehringer Ingelheim Investigational Site Burgdorf
Germany Boehringer Ingelheim Investigational Site Burglengenfeld
Germany Boehringer Ingelheim Investigational Site Burscheid
Germany Boehringer Ingelheim Investigational Site 1 Butzbach
Germany Boehringer Ingelheim Investigational Site 2 Butzbach
Germany Boehringer Ingelheim Investigational Site Buxtehude
Germany Boehringer Ingelheim Investigational Site Calw
Germany Boehringer Ingelheim Investigational Site 1 Celle
Germany Boehringer Ingelheim Investigational Site 2 Celle
Germany Boehringer Ingelheim Investigational Site 1 Chemnitz
Germany Boehringer Ingelheim Investigational Site 2 Chemnitz
Germany Boehringer Ingelheim Investigational Site 3 Chemnitz
Germany Boehringer Ingelheim Investigational Site 4 Chemnitz
Germany Boehringer Ingelheim Investigational Site 5 Chemnitz
Germany Boehringer Ingelheim Investigational Site Coburg
Germany Boehringer Ingelheim Investigational Site Coesfeld
Germany Boehringer Ingelheim Investigational Site Cottbus
Germany Boehringer Ingelheim Investigational Site 1 Crimmitschau
Germany Boehringer Ingelheim Investigational Site 2 Crimmitschau
Germany Boehringer Ingelheim Investigational Site Dachau
Germany Boehringer Ingelheim Investigational Site Delbrück
Germany Boehringer Ingelheim Investigational Site Delmenhorst
Germany Boehringer Ingelheim Investigational Site Dernau
Germany Boehringer Ingelheim Investigational Site 1 Dessau
Germany Boehringer Ingelheim Investigational Site 2 Dessau
Germany Boehringer Ingelheim Investigational Site 3 Dessau
Germany Boehringer Ingelheim Investigational Site 4 Dessau
Germany Boehringer Ingelheim Investigational Site 1 Dietzenbach
Germany Boehringer Ingelheim Investigational Site 2 Dietzenbach
Germany Boehringer Ingelheim Investigational Site 3 Dietzenbach
Germany Boehringer Ingelheim Investigational Site Dillingen
Germany Boehringer Ingelheim Investigational Site Dinkelsbühl
Germany Boehringer Ingelheim Investigational Site 1 Dippoldiswalde
Germany Boehringer Ingelheim Investigational Site 2 Dippoldiswalde
Germany Boehringer Ingelheim Investigational Site Döbeln
Germany Boehringer Ingelheim Investigational Site 1 Dörentrup
Germany Boehringer Ingelheim Investigational Site 2 Dörentrup
Germany Boehringer Ingelheim Investigational Site 1 Dortmund
Germany Boehringer Ingelheim Investigational Site 2 Dortmund
Germany Boehringer Ingelheim Investigational Site 3 Dortmund
Germany Boehringer Ingelheim Investigational Site 4 Dortmund
Germany Boehringer Ingelheim Investigational Site 1 Dresden
Germany Boehringer Ingelheim Investigational Site 2 Dresden
Germany Boehringer Ingelheim Investigational Site 3 Dresden
Germany Boehringer Ingelheim Investigational Site Driedorf
Germany Boehringer Ingelheim Investigational Site Duderstadt
Germany Boehringer Ingelheim Investigational Site 1 Duisburg
Germany Boehringer Ingelheim Investigational Site 2 Duisburg
Germany Boehringer Ingelheim Investigational Site 3 Duisburg
Germany Boehringer Ingelheim Investigational Site Durmersheim
Germany Boehringer Ingelheim Investigational Site 1 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 2 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 3 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 4 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 5 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 6 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 7 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 8 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 9 Düsseldorf
Germany Boehringer Ingelheim Investigational Site Ebermannstadt
Germany Boehringer Ingelheim Investigational Site 1 Edingen-Neckarhausen
Germany Boehringer Ingelheim Investigational Site 2 Edingen-Neckarhausen
Germany Boehringer Ingelheim Investigational Site Edling
Germany Boehringer Ingelheim Investigational Site Eilenburg
Germany Boehringer Ingelheim Investigational Site 1 Eisenach
Germany Boehringer Ingelheim Investigational Site 2 Eisenach
Germany Boehringer Ingelheim Investigational Site Eisenberg
Germany Boehringer Ingelheim Investigational Site Eisenhüttenstadt
Germany Boehringer Ingelheim Investigational Site Ellwangen
Germany Boehringer Ingelheim Investigational Site Emmendingen
Germany Boehringer Ingelheim Investigational Site Emsdetten
Germany Boehringer Ingelheim Investigational Site Emskirchen
Germany Boehringer Ingelheim Investigational Site Enkirch
Germany Boehringer Ingelheim Investigational Site Ennigerloh
Germany Boehringer Ingelheim Investigational Site Eppelheim
Germany Boehringer Ingelheim Investigational Site 1 Erbach
Germany Boehringer Ingelheim Investigational Site 2 Erbach
Germany Boehringer Ingelheim Investigational Site 3 Erbach
Germany Boehringer Ingelheim Investigational Site 1 Erfurt
Germany Boehringer Ingelheim Investigational Site 2 Erfurt
Germany Boehringer Ingelheim Investigational Site 3 Erfurt
Germany Boehringer Ingelheim Investigational Site Erkrath
Germany Boehringer Ingelheim Investigational Site 1 Erlangen
Germany Boehringer Ingelheim Investigational Site Eschborn
Germany Boehringer Ingelheim Investigational Site Eschlkam
Germany Boehringer Ingelheim Investigational Site 1 Essen
Germany Boehringer Ingelheim Investigational Site 10 Essen
Germany Boehringer Ingelheim Investigational Site 11 Essen
Germany Boehringer Ingelheim Investigational Site 12 Essen
Germany Boehringer Ingelheim Investigational Site 13 Essen
Germany Boehringer Ingelheim Investigational Site 14 Essen
Germany Boehringer Ingelheim Investigational Site 2 Essen
Germany Boehringer Ingelheim Investigational Site 3 Essen
Germany Boehringer Ingelheim Investigational Site 4 Essen
Germany Boehringer Ingelheim Investigational Site 5 Essen
Germany Boehringer Ingelheim Investigational Site 6 Essen
Germany Boehringer Ingelheim Investigational Site 7 Essen
Germany Boehringer Ingelheim Investigational Site 8 Essen
Germany Boehringer Ingelheim Investigational Site 9 Essen
Germany Boehringer Ingelheim Investigational Site Ettlingen
Germany Boehringer Ingelheim Investigational Site Extertal
Germany Boehringer Ingelheim Investigational Site Falkenhagen
Germany Boehringer Ingelheim Investigational Site Fehrbellin
Germany Boehringer Ingelheim Investigational Site Flintbek
Germany Boehringer Ingelheim Investigational Site 1 Frankfurt
Germany Boehringer Ingelheim Investigational Site 2 Frankfurt
Germany Boehringer Ingelheim Investigational Site 3 Frankfurt
Germany Boehringer Ingelheim Investigational Site Freiberg
Germany Boehringer Ingelheim Investigational Site 1 Freiburg
Germany Boehringer Ingelheim Investigational Site 2 Freiburg
Germany Boehringer Ingelheim Investigational Site 3 Freiburg
Germany Boehringer Ingelheim Investigational Site 4 Freiburg
Germany Boehringer Ingelheim Investigational Site 5 Freiburg
Germany Boehringer Ingelheim Investigational Site Freilassing
Germany Boehringer Ingelheim Investigational Site Freinsheim
Germany Boehringer Ingelheim Investigational Site 1 Freital
Germany Boehringer Ingelheim Investigational Site 2 Freital
Germany Boehringer Ingelheim Investigational Site 3 Freital
Germany Boehringer Ingelheim Investigational Site Friedrichshafen
Germany Boehringer Ingelheim Investigational Site 1 Friedrichsthal
Germany Boehringer Ingelheim Investigational Site 2 Friedrichsthal
Germany Boehringer Ingelheim Investigational Site Fulda
Germany Boehringer Ingelheim Investigational Site Fürstenfeldbruck
Germany Boehringer Ingelheim Investigational Site 1 Fürstenwalde
Germany Boehringer Ingelheim Investigational Site 2 Fürstenwalde
Germany Boehringer Ingelheim Investigational Site Fürstenzell
Germany Boehringer Ingelheim Investigational Site 1 Fürth
Germany Boehringer Ingelheim Investigational Site 2 Fürth
Germany Boehringer Ingelheim Investigational Site Gauting
Germany Boehringer Ingelheim Investigational Site Geisenhausen
Germany Boehringer Ingelheim Investigational Site Geithain
Germany Boehringer Ingelheim Investigational Site 1 Gelnhausen
Germany Boehringer Ingelheim Investigational Site 2 Gelnhausen
Germany Boehringer Ingelheim Investigational Site 1 Gelsenkirchen
Germany Boehringer Ingelheim Investigational Site 2 Gelsenkirchen
Germany Boehringer Ingelheim Investigational Site 3 Gelsenkirchen
Germany Boehringer Ingelheim Investigational Site 4 Gelsenkirchen
Germany Boehringer Ingelheim Investigational Site Gera
Germany Boehringer Ingelheim Investigational Site Gerbstedt
Germany Boehringer Ingelheim Investigational Site Germering
Germany Boehringer Ingelheim Investigational Site Gersthofen
Germany Boehringer Ingelheim Investigational Site Gingen
Germany Boehringer Ingelheim Investigational Site Gladbeck
Germany Boehringer Ingelheim Investigational Site Gladenbach
Germany Boehringer Ingelheim Investigational Site Glauchau
Germany Boehringer Ingelheim Investigational Site Gleichen
Germany Boehringer Ingelheim Investigational Site Glienicke
Germany Boehringer Ingelheim Investigational Site Glücksburg
Germany Boehringer Ingelheim Investigational Site Göppingen
Germany Boehringer Ingelheim Investigational Site Gosheim
Germany Boehringer Ingelheim Investigational Site Gößweinstein
Germany Boehringer Ingelheim Investigational Site 1 Göttingen
Germany Boehringer Ingelheim Investigational Site 2 Göttingen
Germany Boehringer Ingelheim Investigational Site 3 Göttingen
Germany Boehringer Ingelheim Investigational Site 4 Göttingen
Germany Boehringer Ingelheim Investigational Site 5 Göttingen
Germany Boehringer Ingelheim Investigational Site Greifswald
Germany Boehringer Ingelheim Investigational Site Greven
Germany Boehringer Ingelheim Investigational Site Grevenbroich
Germany Boehringer Ingelheim Investigational Site 1 Grömitz
Germany Boehringer Ingelheim Investigational Site 2 Grömitz
Germany Boehringer Ingelheim Investigational Site Großefehn
Germany Boehringer Ingelheim Investigational Site Großmaischeid
Germany Boehringer Ingelheim Investigational Site Grüna
Germany Boehringer Ingelheim Investigational Site Grünheide
Germany Boehringer Ingelheim Investigational Site Grünstadt
Germany Boehringer Ingelheim Investigational Site Gudensberg
Germany Boehringer Ingelheim Investigational Site Gundelfingen
Germany Boehringer Ingelheim Investigational Site Güster
Germany Boehringer Ingelheim Investigational Site Haag
Germany Boehringer Ingelheim Investigational Site Halbe
Germany Boehringer Ingelheim Investigational Site 1 Halle
Germany Boehringer Ingelheim Investigational Site 2 Halle
Germany Boehringer Ingelheim Investigational Site 3 Halle
Germany Boehringer Ingelheim Investigational Site 4 Halle
Germany Boehringer Ingelheim Investigational Site 5 Halle
Germany Boehringer Ingelheim Investigational Site 1 Hamburg
Germany Boehringer Ingelheim Investigational Site 10 Hamburg
Germany Boehringer Ingelheim Investigational Site 11 Hamburg
Germany Boehringer Ingelheim Investigational Site 12 Hamburg
Germany Boehringer Ingelheim Investigational Site 13 Hamburg
Germany Boehringer Ingelheim Investigational Site 14 Hamburg
Germany Boehringer Ingelheim Investigational Site 15 Hamburg
Germany Boehringer Ingelheim Investigational Site 16 Hamburg
Germany Boehringer Ingelheim Investigational Site 17 Hamburg
Germany Boehringer Ingelheim Investigational Site 18 Hamburg
Germany Boehringer Ingelheim Investigational Site 19 Hamburg
Germany Boehringer Ingelheim Investigational Site 2 Hamburg
Germany Boehringer Ingelheim Investigational Site 20 Hamburg
Germany Boehringer Ingelheim Investigational Site 21 Hamburg
Germany Boehringer Ingelheim Investigational Site 22 Hamburg
Germany Boehringer Ingelheim Investigational Site 23 Hamburg
Germany Boehringer Ingelheim Investigational Site 24 Hamburg
Germany Boehringer Ingelheim Investigational Site 25 Hamburg
Germany Boehringer Ingelheim Investigational Site 3 Hamburg
Germany Boehringer Ingelheim Investigational Site 4 Hamburg
Germany Boehringer Ingelheim Investigational Site 5 Hamburg
Germany Boehringer Ingelheim Investigational Site 6 Hamburg
Germany Boehringer Ingelheim Investigational Site 7 Hamburg
Germany Boehringer Ingelheim Investigational Site 8 Hamburg
Germany Boehringer Ingelheim Investigational Site 9 Hamburg
Germany Boehringer Ingelheim Investigational Site Hameln
Germany Boehringer Ingelheim Investigational Site Hammelburg
Germany Boehringer Ingelheim Investigational Site Hamminkeln
Germany Boehringer Ingelheim Investigational Site Hann Münden
Germany Boehringer Ingelheim Investigational Site 1 Hannover
Germany Boehringer Ingelheim Investigational Site 2 Hannover
Germany Boehringer Ingelheim Investigational Site 3 Hannover
Germany Boehringer Ingelheim Investigational Site 4 Hannover
Germany Boehringer Ingelheim Investigational Site 5 Hannover
Germany Boehringer Ingelheim Investigational Site 6 Hannover
Germany Boehringer Ingelheim Investigational Site 7 Hannover
Germany Boehringer Ingelheim Investigational Site 1 Harsewinkel
Germany Boehringer Ingelheim Investigational Site 2 Harsewinkel
Germany Boehringer Ingelheim Investigational Site 3 Harsewinkel
Germany Boehringer Ingelheim Investigational Site Hartenstein
Germany Boehringer Ingelheim Investigational Site Hasbergen
Germany Boehringer Ingelheim Investigational Site Heilbad Heiligenstadt
Germany Boehringer Ingelheim Investigational Site 1 Heilbronn
Germany Boehringer Ingelheim Investigational Site 2 Heilbronn
Germany Boehringer Ingelheim Investigational Site 3 Heilbronn
Germany Boehringer Ingelheim Investigational Site Heinsberg
Germany Boehringer Ingelheim Investigational Site Herborn
Germany Boehringer Ingelheim Investigational Site Herbrechtingen
Germany Boehringer Ingelheim Investigational Site Herdorf
Germany Boehringer Ingelheim Investigational Site Herne
Germany Boehringer Ingelheim Investigational Site Herrenberg
Germany Boehringer Ingelheim Investigational Site Herrnhut
Germany Boehringer Ingelheim Investigational Site Herrsching
Germany Boehringer Ingelheim Investigational Site 1 Herzogenrath
Germany Boehringer Ingelheim Investigational Site 2 Herzogenrath
Germany Boehringer Ingelheim Investigational Site Hessisch Lichtenau
Germany Boehringer Ingelheim Investigational Site Hettstedt
Germany Boehringer Ingelheim Investigational Site Hildburghausen
Germany Boehringer Ingelheim Investigational Site 1 Hildesheim
Germany Boehringer Ingelheim Investigational Site 2 Hildesheim
Germany Boehringer Ingelheim Investigational Site 3 Hildesheim
Germany Boehringer Ingelheim Investigational Site 4 Hildesheim
Germany Boehringer Ingelheim Investigational Site Höchberg
Germany Boehringer Ingelheim Investigational Site 1 Hof
Germany Boehringer Ingelheim Investigational Site 2 Hof
Germany Boehringer Ingelheim Investigational Site Hohenprießnitz
Germany Boehringer Ingelheim Investigational Site Holle
Germany Boehringer Ingelheim Investigational Site Horb
Germany Boehringer Ingelheim Investigational Site Hückeswagen
Germany Boehringer Ingelheim Investigational Site 1 Hüllhorst
Germany Boehringer Ingelheim Investigational Site 2 Hüllhorst
Germany Boehringer Ingelheim Investigational Site 3 Hüllhorst
Germany Boehringer Ingelheim Investigational Site 1 Hürth
Germany Boehringer Ingelheim Investigational Site 2 Hürth
Germany Boehringer Ingelheim Investigational Site Ibbenbüren
Germany Boehringer Ingelheim Investigational Site 1 Ilmenau
Germany Boehringer Ingelheim Investigational Site 2 Ilmenau
Germany Boehringer Ingelheim Investigational Site Immenstadt
Germany Boehringer Ingelheim Investigational Site Ingelfingen
Germany Boehringer Ingelheim Investigational Site Ingelheim
Germany Boehringer Ingelheim Investigational Site Ingolstadt
Germany Boehringer Ingelheim Investigational Site Inning
Germany Boehringer Ingelheim Investigational Site Irsch
Germany Boehringer Ingelheim Investigational Site 1 Iserlohn
Germany Boehringer Ingelheim Investigational Site 2 Iserlohn
Germany Boehringer Ingelheim Investigational Site 1 Itzehoe
Germany Boehringer Ingelheim Investigational Site 2 Itzehoe
Germany Boehringer Ingelheim Investigational Site 3 Itzehoe
Germany Boehringer Ingelheim Investigational Site Jettingen
Germany Boehringer Ingelheim Investigational Site 1 Jülich
Germany Boehringer Ingelheim Investigational Site 2 Jülich
Germany Boehringer Ingelheim Investigational Site 3 Jülich
Germany Boehringer Ingelheim Investigational Site 1 Jüterbog
Germany Boehringer Ingelheim Investigational Site 2 Jüterbog
Germany Boehringer Ingelheim Investigational Site 1 Kaiserslautern
Germany Boehringer Ingelheim Investigational Site 2 Kaiserslautern
Germany Boehringer Ingelheim Investigational Site Kamen
Germany Boehringer Ingelheim Investigational Site Kandel
Germany Boehringer Ingelheim Investigational Site Karlsfeld
Germany Boehringer Ingelheim Investigational Site 1 Karlsruhe
Germany Boehringer Ingelheim Investigational Site 2 Karlsruhe
Germany Boehringer Ingelheim Investigational Site 1 Kassel
Germany Boehringer Ingelheim Investigational Site 2 Kassel
Germany Boehringer Ingelheim Investigational Site 3 Kassel
Germany Boehringer Ingelheim Investigational Site 4 Kassel
Germany Boehringer Ingelheim Investigational Site 1 Kaufbeuren
Germany Boehringer Ingelheim Investigational Site 2 Kaufbeuren
Germany Boehringer Ingelheim Investigational Site 3 Kaufbeuren
Germany Boehringer Ingelheim Investigational Site 1 Kempten
Germany Boehringer Ingelheim Investigational Site 2 Kempten
Germany Boehringer Ingelheim Investigational Site Kenzingen
Germany Boehringer Ingelheim Investigational Site Kernen
Germany Boehringer Ingelheim Investigational Site Kiel
Germany Boehringer Ingelheim Investigational Site Kirchardt
Germany Boehringer Ingelheim Investigational Site Kirchen
Germany Boehringer Ingelheim Investigational Site Kirchheim
Germany Boehringer Ingelheim Investigational Site Kirchheimbolanden
Germany Boehringer Ingelheim Investigational Site Kißlegg
Germany Boehringer Ingelheim Investigational Site Kleve
Germany Boehringer Ingelheim Investigational Site Klingenberg
Germany Boehringer Ingelheim Investigational Site 1 Köln
Germany Boehringer Ingelheim Investigational Site 2 Köln
Germany Boehringer Ingelheim Investigational Site 3 Köln
Germany Boehringer Ingelheim Investigational Site 4 Köln
Germany Boehringer Ingelheim Investigational Site 5 Köln
Germany Boehringer Ingelheim Investigational Site 6 Köln
Germany Boehringer Ingelheim Investigational Site 7 Köln
Germany Boehringer Ingelheim Investigational Site 8 Köln
Germany Boehringer Ingelheim Investigational Site 9 Köln
Germany Boehringer Ingelheim Investigational Site Königsbrunn
Germany Boehringer Ingelheim Investigational Site Konz
Germany Boehringer Ingelheim Investigational Site Kösching
Germany Boehringer Ingelheim Investigational Site Köthen
Germany Boehringer Ingelheim Investigational Site Krefeld
Germany Boehringer Ingelheim Investigational Site Kreuztal
Germany Boehringer Ingelheim Investigational Site Kronach
Germany Boehringer Ingelheim Investigational Site Laage
Germany Boehringer Ingelheim Investigational Site Lahnau
Germany Boehringer Ingelheim Investigational Site Laichingen
Germany Boehringer Ingelheim Investigational Site Lampertheim
Germany Boehringer Ingelheim Investigational Site Landshut
Germany Boehringer Ingelheim Investigational Site Langen
Germany Boehringer Ingelheim Investigational Site Langerwehe
Germany Boehringer Ingelheim Investigational Site Lauterbach
Germany Boehringer Ingelheim Investigational Site 1 Leipzig
Germany Boehringer Ingelheim Investigational Site 2 Leipzig
Germany Boehringer Ingelheim Investigational Site 3 Leipzig
Germany Boehringer Ingelheim Investigational Site 4 Leipzig
Germany Boehringer Ingelheim Investigational Site 5 Leipzig
Germany Boehringer Ingelheim Investigational Site 6 Leipzig
Germany Boehringer Ingelheim Investigational Site 7 Leipzig
Germany Boehringer Ingelheim Investigational Site 8 Leipzig
Germany Boehringer Ingelheim Investigational Site 9 Leipzig
Germany Boehringer Ingelheim Investigational Site Leverkusen
Germany Boehringer Ingelheim Investigational Site Lichtenfels
Germany Boehringer Ingelheim Investigational Site 1 Limburg
Germany Boehringer Ingelheim Investigational Site 2 Limburg
Germany Boehringer Ingelheim Investigational Site 1 Limburgerhof
Germany Boehringer Ingelheim Investigational Site 2 Limburgerhof
Germany Boehringer Ingelheim Investigational Site Lingen
Germany Boehringer Ingelheim Investigational Site Linz
Germany Boehringer Ingelheim Investigational Site Lippstadt
Germany Boehringer Ingelheim Investigational Site Lohr
Germany Boehringer Ingelheim Investigational Site Lübbenau
Germany Boehringer Ingelheim Investigational Site Lübeck
Germany Boehringer Ingelheim Investigational Site 1 Lüdenscheid
Germany Boehringer Ingelheim Investigational Site 2 Lüdenscheid
Germany Boehringer Ingelheim Investigational Site Ludwigsfelde
Germany Boehringer Ingelheim Investigational Site 1 Ludwigshafen
Germany Boehringer Ingelheim Investigational Site 2 Ludwigshafen
Germany Boehringer Ingelheim Investigational Site 1 Lüneburg
Germany Boehringer Ingelheim Investigational Site 2 Lüneburg
Germany Boehringer Ingelheim Investigational Site 1 Magdeburg
Germany Boehringer Ingelheim Investigational Site 2 Magdeburg
Germany Boehringer Ingelheim Investigational Site Mainaschaff
Germany Boehringer Ingelheim Investigational Site 1 Mannheim
Germany Boehringer Ingelheim Investigational Site 2 Mannheim
Germany Boehringer Ingelheim Investigational Site 3 Mannheim
Germany Boehringer Ingelheim Investigational Site 4 Mannheim
Germany Boehringer Ingelheim Investigational Site 5 Mannheim
Germany Boehringer Ingelheim Investigational Site 6 Mannheim
Germany Boehringer Ingelheim Investigational Site 7 Mannheim
Germany Boehringer Ingelheim Investigational Site Margetshöchheim
Germany Boehringer Ingelheim Investigational Site Markdorf
Germany Boehringer Ingelheim Investigational Site Markkleeberg
Germany Boehringer Ingelheim Investigational Site 1 Marl
Germany Boehringer Ingelheim Investigational Site 2 Marl
Germany Boehringer Ingelheim Investigational Site Mayen
Germany Boehringer Ingelheim Investigational Site Meckenheim
Germany Boehringer Ingelheim Investigational Site Meerbusch
Germany Boehringer Ingelheim Investigational Site Meinhard
Germany Boehringer Ingelheim Investigational Site Meißen
Germany Boehringer Ingelheim Investigational Site Mendig
Germany Boehringer Ingelheim Investigational Site Merseburg
Germany Boehringer Ingelheim Investigational Site Metzingen
Germany Boehringer Ingelheim Investigational Site Mittenwald
Germany Boehringer Ingelheim Investigational Site Mitterfelden
Germany Boehringer Ingelheim Investigational Site Molfsee
Germany Boehringer Ingelheim Investigational Site 1 Mönchengladbach
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Germany Boehringer Ingelheim Investigational Site 1 Wuppertal
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Germany Boehringer Ingelheim Investigational Site 2 Zwickau
Germany Boehringer Ingelheim Investigational Site Zwönitz

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to Visit 3 No
Primary 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. Baseline to Visit 3 No
Primary 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. Baseline to Visit 3 No
Secondary 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. Baseline to Visit 3 No
Secondary 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. Baseline to Visit 3 No
Secondary Behavioural Changes During Treatment Number of patients with occurence of behavioural changes in terms of impulse control disorders Baseline to Visit 3 Yes
See also
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Terminated NCT01192503 - Safety and Efficacy of Rasagiline in Restless Legs Syndrome Phase 2/Phase 3
Completed NCT00530530 - ASP8825 - Study in Patients With Restless Legs Syndrome Phase 2
Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
Completed NCT00375284 - A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS Phase 4
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00479531 - Sequential Compression Devices for Treatment of Restless Legs Syndrome Phase 3
Recruiting NCT05581576 - Pitolisant in Refractory Restless Legs Syndrome Phase 4
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Recruiting NCT05044520 - Clinical Features Associated With Restless Legs Syndrome.
Withdrawn NCT03849001 - Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS N/A
Completed NCT03076541 - Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements. N/A
Recruiting NCT04145674 - A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo Phase 2
Completed NCT02532608 - Infra-slow Oscillations During Sleep N/A
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT00748098 - Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance Phase 3

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