Restless Legs Syndrome Clinical Trial
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.
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. |
Time Perspective: Prospective
Country | Name | City | State |
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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 | |
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Germany | Boehringer Ingelheim Investigational Site 3 | Neuss | |
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Germany | Boehringer Ingelheim Investigational Site | Niederlehme | |
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Germany | Boehringer Ingelheim Investigational Site 4 | Regensburg | |
Germany | Boehringer Ingelheim Investigational Site | Reichenbach | |
Germany | Boehringer Ingelheim Investigational Site | Reinbek | |
Germany | Boehringer Ingelheim Investigational Site 1 | Remscheid | |
Germany | Boehringer Ingelheim Investigational Site 2 | Remscheid | |
Germany | Boehringer Ingelheim Investigational Site 3 | Remscheid | |
Germany | Boehringer Ingelheim Investigational Site 4 | Remscheid | |
Germany | Boehringer Ingelheim Investigational Site 5 | Remscheid | |
Germany | Boehringer Ingelheim Investigational Site 6 | Remscheid | |
Germany | Boehringer Ingelheim Investigational Site | Rendsburg | |
Germany | Boehringer Ingelheim Investigational Site | Rheine | |
Germany | Boehringer Ingelheim Investigational Site | Röcknitz | |
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Germany | Boehringer Ingelheim Investigational Site 3 | Rostock | |
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Germany | Boehringer Ingelheim Investigational Site | Rüsselsheim | |
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Germany | Boehringer Ingelheim Investigational Site 1 | Schwäbisch Gmünd | |
Germany | Boehringer Ingelheim Investigational Site 2 | Schwäbisch Gmünd | |
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Germany | Boehringer Ingelheim Investigational Site 1 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 10 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 11 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 2 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 3 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 4 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 5 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 6 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 7 | Stuttgart | |
Germany | Boehringer Ingelheim Investigational Site 8 | Stuttgart | |
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Germany | Boehringer Ingelheim Investigational Site 1 | Westoverledingen | |
Germany | Boehringer Ingelheim Investigational Site 2 | Westoverledingen | |
Germany | Boehringer Ingelheim Investigational Site 1 | Wiesbaden | |
Germany | Boehringer Ingelheim Investigational Site 2 | Wiesbaden | |
Germany | Boehringer Ingelheim Investigational Site 3 | Wiesbaden | |
Germany | Boehringer Ingelheim Investigational Site | Wiesenfelden | |
Germany | Boehringer Ingelheim Investigational Site | Wietzen | |
Germany | Boehringer Ingelheim Investigational Site | Wildau | |
Germany | Boehringer Ingelheim Investigational Site | Wilhelmshaven | |
Germany | Boehringer Ingelheim Investigational Site | Wilhermsdorf | |
Germany | Boehringer Ingelheim Investigational Site | Willich | |
Germany | Boehringer Ingelheim Investigational Site | Winkelhaid | |
Germany | Boehringer Ingelheim Investigational Site | Winsen | |
Germany | Boehringer Ingelheim Investigational Site 1 | Wismar | |
Germany | Boehringer Ingelheim Investigational Site 2 | Wismar | |
Germany | Boehringer Ingelheim Investigational Site 3 | Wismar | |
Germany | Boehringer Ingelheim Investigational Site | Wissen | |
Germany | Boehringer Ingelheim Investigational Site | Wittgensdorf | |
Germany | Boehringer Ingelheim Investigational Site 1 | Witzenhausen | |
Germany | Boehringer Ingelheim Investigational Site 2 | Witzenhausen | |
Germany | Boehringer Ingelheim Investigational Site 3 | Witzenhausen | |
Germany | Boehringer Ingelheim Investigational Site | Wolfenbüttel | |
Germany | Boehringer Ingelheim Investigational Site 1 | Wolfratshausen | |
Germany | Boehringer Ingelheim Investigational Site 2 | Wolfratshausen | |
Germany | Boehringer Ingelheim Investigational Site 3 | Wolfratshausen | |
Germany | Boehringer Ingelheim Investigational Site | Wolfsburg | |
Germany | Boehringer Ingelheim Investigational Site 1 | Wolgast | |
Germany | Boehringer Ingelheim Investigational Site | Worms | |
Germany | Boehringer Ingelheim Investigational Site | Wörrstadt | |
Germany | Boehringer Ingelheim Investigational Site 1 | Wörth | |
Germany | Boehringer Ingelheim Investigational Site 2 | Wörth | |
Germany | Boehringer Ingelheim Investigational Site | Wunstorf | |
Germany | Boehringer Ingelheim Investigational Site 1 | Wuppertal | |
Germany | Boehringer Ingelheim Investigational Site 2 | Wuppertal | |
Germany | Boehringer Ingelheim Investigational Site 3 | Wuppertal | |
Germany | Boehringer Ingelheim Investigational Site 4 | Wuppertal | |
Germany | Boehringer Ingelheim Investigational Site | Würzburg | |
Germany | Boehringer Ingelheim Investigational Site | Wustrau | |
Germany | Boehringer Ingelheim Investigational Site | Zeitz | |
Germany | Boehringer Ingelheim Investigational Site | Zella-Mehlis | |
Germany | Boehringer Ingelheim Investigational Site | Zerbst | |
Germany | Boehringer Ingelheim Investigational Site | Ziltendorf | |
Germany | Boehringer Ingelheim Investigational Site | Zirndorf | |
Germany | Boehringer Ingelheim Investigational Site | Zorge | |
Germany | Boehringer Ingelheim Investigational Site | Zschopau | |
Germany | Boehringer Ingelheim Investigational Site 1 | Zwickau | |
Germany | Boehringer Ingelheim Investigational Site 2 | Zwickau | |
Germany | Boehringer Ingelheim Investigational Site | Zwönitz |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Germany,
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 |
Status | Clinical Trial | Phase | |
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Recruiting |
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Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
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Phase 1/Phase 2 | |
Recruiting |
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Impact of Iron Supplementation Treatment on Brain Iron Concentrations
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Completed |
NCT05787080 -
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)
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N/A | |
Not yet recruiting |
NCT05529095 -
Sublingual Apomorphine in Refractory Restless Legs Syndrome
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Phase 4 | |
Recruiting |
NCT05044520 -
Clinical Features Associated With Restless Legs Syndrome.
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Withdrawn |
NCT03849001 -
Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS
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N/A | |
Completed |
NCT03076541 -
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
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N/A | |
Recruiting |
NCT04145674 -
A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo
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Phase 2 | |
Completed |
NCT02532608 -
Infra-slow Oscillations During Sleep
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N/A | |
Completed |
NCT01528462 -
Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
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Completed |
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Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
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Phase 3 |