Restless Legs Syndrome Clinical Trial
Official title:
Sifrol® (Pramipexole) Impact on RLS Related Quality of Life: A 12-weeks Observational Study in Patients With Primary RLS
| NCT number | NCT00539461 |
| Other study ID # | 248.638 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | September 28, 2007 |
| Last updated | October 31, 2013 |
| Start date | February 2007 |
In this German non-interventional observational study 1980 patients diagnosed with Restless
Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal
states in Germany. Both moderate to severe RLS patients, with or without previous RLS
treatment, suffering from RLS symptoms like a desire to move the extremities usually
associated with some discomfort, motor restlessness and worsening of symptoms at rest with
at least temporary relief by activity, worsening of symptoms later in the day or at night,
are eligible for this study, if it is planned to initiate therapy with pramipexole or to add
pramipexole to a previously given, insufficient therapy. Three visits are planned to be
documented in this PMS study, one baseline visit, visit two after the end of pramipexole
titration and visit three after 12 weeks of treatment. Evaluations and visits are to be
carried out and documented only if part of routine medical practice. The main goal of
observational studies is to determine how pramipexole treatment works when applied in actual
practice and thus maximise external validity. In actual practice patients who have been
excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e.
those with certain disease histories, co-morbidities and/or demographic characteristics)
will be treated with PPX. Thus in addition during this observational study information on
the efficacy and safety of PPX in those patients will be obtained. The objectives of this
PMS study are:
- To evaluate the treatment effect of pramipexole on RLS severity and general improvement
as measured by IRLS and CGI-I.
- To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome
Quality of Life questionnaire (RLS-QoL).
- To evaluate the safety profile of PPX in a natural study population.
| Status | Completed |
| Enrollment | 2023 |
| Est. completion date | |
| Est. primary completion date | November 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Diagnosis of primary RLS 2. Indication for RLS treatment with Sifrol® (pramipexole) 3. Male or female patients aged at least 18 years. Exclusion Criteria: 1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients. 2. Ongoing treatment with Sifrol® (pramipexole). |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Boehringer Ingelheim Investigational Site | Aalen | |
| Germany | Boehringer Ingelheim Investigational Site | Aarbergen | |
| Germany | Boehringer Ingelheim Investigational Site | Adendorf | |
| Germany | Boehringer Ingelheim Investigational Site | Aham | |
| Germany | Boehringer Ingelheim Investigational Site | Ahaus | |
| Germany | Boehringer Ingelheim Investigational Site | Ahlen | |
| Germany | Boehringer Ingelheim Investigational Site | Ahorntal | |
| Germany | Boehringer Ingelheim Investigational Site | Aichach | |
| Germany | Boehringer Ingelheim Investigational Site | Aislingen | |
| Germany | Boehringer Ingelheim Investigational Site | Albstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Aldenhoven | |
| Germany | Boehringer Ingelheim Investigational Site | Aldingen | |
| Germany | Boehringer Ingelheim Investigational Site | Alfeld | |
| Germany | Boehringer Ingelheim Investigational Site | Alpirsbach | |
| Germany | Boehringer Ingelheim Investigational Site | Alsdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Altena | |
| Germany | Boehringer Ingelheim Investigational Site | Altenstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Altomünster | |
| Germany | Boehringer Ingelheim Investigational Site | Alveslohe | |
| Germany | Boehringer Ingelheim Investigational Site | Amberg | |
| Germany | Boehringer Ingelheim Investigational Site | Ammerbuch | |
| Germany | Boehringer Ingelheim Investigational Site | Andernach | |
| Germany | Boehringer Ingelheim Investigational Site | Anklam | |
| Germany | Boehringer Ingelheim Investigational Site | Apolda | |
| Germany | Boehringer Ingelheim Investigational Site | Armsheim | |
| Germany | Boehringer Ingelheim Investigational Site | Arzberg | |
| Germany | Boehringer Ingelheim Investigational Site | Aschaffenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Aschersleben | |
| Germany | Boehringer Ingelheim Investigational Site | Aschheim | |
| Germany | Boehringer Ingelheim Investigational Site | Attendorn | |
| Germany | Boehringer Ingelheim Investigational Site | Auerbach | |
| Germany | Boehringer Ingelheim Investigational Site | Augsburg | |
| Germany | Boehringer Ingelheim Investigational Site | Aurich | |
| Germany | Boehringer Ingelheim Investigational Site | Babensham | |
| Germany | Boehringer Ingelheim Investigational Site | Backnang | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Arolsen | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Berleburg | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Bevensen | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Düben | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Dürrenberg | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Dürrheim | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Ems | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Essen | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Kreuznach | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Laasphe | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Langensalza | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Lausick | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Münstereifel | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Oeynhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Salzungen | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Schwalbach | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Schwartau | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Segeberg | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Tennstedt | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Waldsee | |
| Germany | Boehringer Ingelheim Investigational Site | Baden-Baden | |
| Germany | Boehringer Ingelheim Investigational Site | Bahrdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Baltmannsweiler | |
| Germany | Boehringer Ingelheim Investigational Site | Bamberg | |
| Germany | Boehringer Ingelheim Investigational Site | Barleben | |
| Germany | Boehringer Ingelheim Investigational Site | Bärnau | |
| Germany | Boehringer Ingelheim Investigational Site | Baunatal | |
| Germany | Boehringer Ingelheim Investigational Site | Bautzen | |
| Germany | Boehringer Ingelheim Investigational Site | Bayreuth | |
| Germany | Boehringer Ingelheim Investigational Site | Beckum | |
| Germany | Boehringer Ingelheim Investigational Site | Beeskow | |
| Germany | Boehringer Ingelheim Investigational Site | Bellheim | |
| Germany | Boehringer Ingelheim Investigational Site | Belm | |
| Germany | Boehringer Ingelheim Investigational Site | Bensheim | |
| Germany | Boehringer Ingelheim Investigational Site | Berching | |
| Germany | Boehringer Ingelheim Investigational Site | Bergfelde | |
| Germany | Boehringer Ingelheim Investigational Site | Bergheim | |
| Germany | Boehringer Ingelheim Investigational Site | Bergisch Gladbach | |
| Germany | Boehringer Ingelheim Investigational Site | Berkheim | |
| Germany | Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site | Berne | |
| Germany | Boehringer Ingelheim Investigational Site | Bernsdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Betzdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Biebertal | |
| Germany | Boehringer Ingelheim Investigational Site | Bielefeld | |
| Germany | Boehringer Ingelheim Investigational Site | Bienenbüttel | |
| Germany | Boehringer Ingelheim Investigational Site | Bippen | |
| Germany | Boehringer Ingelheim Investigational Site | Birkenfeld | |
| Germany | Boehringer Ingelheim Investigational Site | Birkenwerder | |
| Germany | Boehringer Ingelheim Investigational Site | Blankenhain | |
| Germany | Boehringer Ingelheim Investigational Site | Blaustein | |
| Germany | Boehringer Ingelheim Investigational Site | Blieskastel | |
| Germany | Boehringer Ingelheim Investigational Site | Bobritzsch | |
| Germany | Boehringer Ingelheim Investigational Site | Bocholt | |
| Germany | Boehringer Ingelheim Investigational Site | Bochum | |
| Germany | Boehringer Ingelheim Investigational Site | Bockenem | |
| Germany | Boehringer Ingelheim Investigational Site | Bodelshausen | |
| Germany | Boehringer Ingelheim Investigational Site | Bodenfelde | |
| Germany | Boehringer Ingelheim Investigational Site | Bodenkirchen | |
| Germany | Boehringer Ingelheim Investigational Site | Bodenwöhr | |
| Germany | Boehringer Ingelheim Investigational Site | Bodman-Ludwigshafen | |
| Germany | Boehringer Ingelheim Investigational Site | Böhlen | |
| Germany | Boehringer Ingelheim Investigational Site | Bollendorf | |
| Germany | Boehringer Ingelheim Investigational Site | Bonn | |
| Germany | Boehringer Ingelheim Investigational Site | Bopfingen | |
| Germany | Boehringer Ingelheim Investigational Site | Borgholzhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Borken | |
| Germany | Boehringer Ingelheim Investigational Site | Borna | |
| Germany | Boehringer Ingelheim Investigational Site | Bornheim | |
| Germany | Boehringer Ingelheim Investigational Site | Bösel | |
| Germany | Boehringer Ingelheim Investigational Site | Bottendorf | |
| Germany | Boehringer Ingelheim Investigational Site | Bottmersdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Bottrop | |
| Germany | Boehringer Ingelheim Investigational Site | Bovenden | |
| Germany | Boehringer Ingelheim Investigational Site | Brake | |
| Germany | Boehringer Ingelheim Investigational Site | Brandenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Brannenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Braunschweig | |
| Germany | Boehringer Ingelheim Investigational Site | Brechen | |
| Germany | Boehringer Ingelheim Investigational Site | Breitenbrunn | |
| Germany | Boehringer Ingelheim Investigational Site | Bremen | |
| Germany | Boehringer Ingelheim Investigational Site | Bremerhaven | |
| Germany | Boehringer Ingelheim Investigational Site | Brensbach | |
| Germany | Boehringer Ingelheim Investigational Site | Breuberg | |
| Germany | Boehringer Ingelheim Investigational Site | Bruchköbel | |
| Germany | Boehringer Ingelheim Investigational Site | Brunsbüttel | |
| Germany | Boehringer Ingelheim Investigational Site | Buchbach | |
| Germany | Boehringer Ingelheim Investigational Site | Bückeburg | |
| Germany | Boehringer Ingelheim Investigational Site | Buckow | |
| Germany | Boehringer Ingelheim Investigational Site | Büdelsdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Bunde | |
| Germany | Boehringer Ingelheim Investigational Site | Burg | |
| Germany | Boehringer Ingelheim Investigational Site | Burgau | |
| Germany | Boehringer Ingelheim Investigational Site | Burgdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Burgpreppach | |
| Germany | Boehringer Ingelheim Investigational Site | Burtenbach | |
| Germany | Boehringer Ingelheim Investigational Site | Büttelborn | |
| Germany | Boehringer Ingelheim Investigational Site | Buttstädt | |
| Germany | Boehringer Ingelheim Investigational Site | Butzbach | |
| Germany | Boehringer Ingelheim Investigational Site | Cadolzburg | |
| Germany | Boehringer Ingelheim Investigational Site | Calbe | |
| Germany | Boehringer Ingelheim Investigational Site | Calberlah | |
| Germany | Boehringer Ingelheim Investigational Site | Castrop-Rauxel | |
| Germany | Boehringer Ingelheim Investigational Site | Celle | |
| Germany | Boehringer Ingelheim Investigational Site | Chemnitz | |
| Germany | Boehringer Ingelheim Investigational Site | Cochem | |
| Germany | Boehringer Ingelheim Investigational Site | Coppenbrügge | |
| Germany | Boehringer Ingelheim Investigational Site | Crimmitschau | |
| Germany | Boehringer Ingelheim Investigational Site | Crivitz | |
| Germany | Boehringer Ingelheim Investigational Site | Cuxhaven | |
| Germany | Boehringer Ingelheim Investigational Site | Dabel | |
| Germany | Boehringer Ingelheim Investigational Site | Darmstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Dassow | |
| Germany | Boehringer Ingelheim Investigational Site | Datteln | |
| Germany | Boehringer Ingelheim Investigational Site | Daun | |
| Germany | Boehringer Ingelheim Investigational Site | Deggendorf | |
| Germany | Boehringer Ingelheim Investigational Site | Deidesheim | |
| Germany | Boehringer Ingelheim Investigational Site | Deining | |
| Germany | Boehringer Ingelheim Investigational Site | Delitzsch | |
| Germany | Boehringer Ingelheim Investigational Site | Demen | |
| Germany | Boehringer Ingelheim Investigational Site | Denkendorf | |
| Germany | Boehringer Ingelheim Investigational Site | Dessau | |
| Germany | Boehringer Ingelheim Investigational Site | Detmold | |
| Germany | Boehringer Ingelheim Investigational Site | Dettenheim | |
| Germany | Boehringer Ingelheim Investigational Site | Deuben | |
| Germany | Boehringer Ingelheim Investigational Site | Deutzen | |
| Germany | Boehringer Ingelheim Investigational Site | Diepholz | |
| Germany | Boehringer Ingelheim Investigational Site | Dillingen | |
| Germany | Boehringer Ingelheim Investigational Site | Dingolfing | |
| Germany | Boehringer Ingelheim Investigational Site | Dinkelsbühl | |
| Germany | Boehringer Ingelheim Investigational Site | Dinslaken | |
| Germany | Boehringer Ingelheim Investigational Site | Dissen | |
| Germany | Boehringer Ingelheim Investigational Site | Dogern | |
| Germany | Boehringer Ingelheim Investigational Site | Dollern | |
| Germany | Boehringer Ingelheim Investigational Site | Donaueschingen | |
| Germany | Boehringer Ingelheim Investigational Site | Dörentrup | |
| Germany | Boehringer Ingelheim Investigational Site | Dormagen | |
| Germany | Boehringer Ingelheim Investigational Site | Dornstetten | |
| Germany | Boehringer Ingelheim Investigational Site | Dörpen | |
| Germany | Boehringer Ingelheim Investigational Site | Dorsten | |
| Germany | Boehringer Ingelheim Investigational Site | Dortmund | |
| Germany | Boehringer Ingelheim Investigational Site | Dreieich | |
| Germany | Boehringer Ingelheim Investigational Site | Drensteinfurt | |
| Germany | Boehringer Ingelheim Investigational Site | Dresden | |
| Germany | Boehringer Ingelheim Investigational Site | Driedorf | |
| Germany | Boehringer Ingelheim Investigational Site | Duderstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Duisburg | |
| Germany | Boehringer Ingelheim Investigational Site | Dummerstorf | |
| Germany | Boehringer Ingelheim Investigational Site | Düren | |
| Germany | Boehringer Ingelheim Investigational Site | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site | Ebergötzen | |
| Germany | Boehringer Ingelheim Investigational Site | Ebermannstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Eberstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Ebhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Edewecht | |
| Germany | Boehringer Ingelheim Investigational Site | Edling | |
| Germany | Boehringer Ingelheim Investigational Site | Egelsbach | |
| Germany | Boehringer Ingelheim Investigational Site | Ehingen | |
| Germany | Boehringer Ingelheim Investigational Site | Eilenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Eisenhüttenstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Eiterfeld | |
| Germany | Boehringer Ingelheim Investigational Site | Eitorf | |
| Germany | Boehringer Ingelheim Investigational Site | Ellwangen | |
| Germany | Boehringer Ingelheim Investigational Site | Elmshorn | |
| Germany | Boehringer Ingelheim Investigational Site | Emersacker | |
| Germany | Boehringer Ingelheim Investigational Site | Emmendingen | |
| Germany | Boehringer Ingelheim Investigational Site | Emsdetten | |
| Germany | Boehringer Ingelheim Investigational Site | Enger | |
| Germany | Boehringer Ingelheim Investigational Site | Enkenbach-Alsenborn | |
| Germany | Boehringer Ingelheim Investigational Site | Ennepetal | |
| Germany | Boehringer Ingelheim Investigational Site | Ennigerloh | |
| Germany | Boehringer Ingelheim Investigational Site | Eppstein | |
| Germany | Boehringer Ingelheim Investigational Site | Erding | |
| Germany | Boehringer Ingelheim Investigational Site | Erftstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Erkrath | |
| Germany | Boehringer Ingelheim Investigational Site | Erligheim | |
| Germany | Boehringer Ingelheim Investigational Site | Erndtebrück | |
| Germany | Boehringer Ingelheim Investigational Site | Erolzheim | |
| Germany | Boehringer Ingelheim Investigational Site | Eschborn | |
| Germany | Boehringer Ingelheim Investigational Site | Eschelbronn | |
| Germany | Boehringer Ingelheim Investigational Site | Eschweiler | |
| Germany | Boehringer Ingelheim Investigational Site | Eslohe | |
| Germany | Boehringer Ingelheim Investigational Site | Espenhain | |
| Germany | Boehringer Ingelheim Investigational Site | Essen | |
| Germany | Boehringer Ingelheim Investigational Site | Esslingen | |
| Germany | Boehringer Ingelheim Investigational Site | Euskirchen | |
| Germany | Boehringer Ingelheim Investigational Site | Filderstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Floh-Seligenthal | |
| Germany | Boehringer Ingelheim Investigational Site | Flöha | |
| Germany | Boehringer Ingelheim Investigational Site | Forbach | |
| Germany | Boehringer Ingelheim Investigational Site | Forchheim | |
| Germany | Boehringer Ingelheim Investigational Site | Frankenberg | |
| Germany | Boehringer Ingelheim Investigational Site | Frankenthal | |
| Germany | Boehringer Ingelheim Investigational Site | Frankfurt | |
| Germany | Boehringer Ingelheim Investigational Site | Freiberg | |
| Germany | Boehringer Ingelheim Investigational Site | Freiburg | |
| Germany | Boehringer Ingelheim Investigational Site | Freigericht | |
| Germany | Boehringer Ingelheim Investigational Site | Freudenstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Freyung | |
| Germany | Boehringer Ingelheim Investigational Site | Friedland | |
| Germany | Boehringer Ingelheim Investigational Site | Friedrichshafen | |
| Germany | Boehringer Ingelheim Investigational Site | Friedrichsthal | |
| Germany | Boehringer Ingelheim Investigational Site | Frohburg | |
| Germany | Boehringer Ingelheim Investigational Site | Fulda | |
| Germany | Boehringer Ingelheim Investigational Site | Fürstenwalde | |
| Germany | Boehringer Ingelheim Investigational Site | Furtwangen | |
| Germany | Boehringer Ingelheim Investigational Site | Füssen | |
| Germany | Boehringer Ingelheim Investigational Site | Gangelt | |
| Germany | Boehringer Ingelheim Investigational Site | Gardelegen | |
| Germany | Boehringer Ingelheim Investigational Site | Garmisch-Partenkirchen | |
| Germany | Boehringer Ingelheim Investigational Site | Gars | |
| Germany | Boehringer Ingelheim Investigational Site | Gaußig | |
| Germany | Boehringer Ingelheim Investigational Site | Gebesee | |
| Germany | Boehringer Ingelheim Investigational Site | Geesthacht | |
| Germany | Boehringer Ingelheim Investigational Site | Gelbensande | |
| Germany | Boehringer Ingelheim Investigational Site | Gelsenkirchen | |
| Germany | Boehringer Ingelheim Investigational Site | Gensingen | |
| Germany | Boehringer Ingelheim Investigational Site | Georgsmarienhütte | |
| Germany | Boehringer Ingelheim Investigational Site | Gera | |
| Germany | Boehringer Ingelheim Investigational Site | Gerbstedt | |
| Germany | Boehringer Ingelheim Investigational Site | Germaringen | |
| Germany | Boehringer Ingelheim Investigational Site | Germering | |
| Germany | Boehringer Ingelheim Investigational Site | Germersheim | |
| Germany | Boehringer Ingelheim Investigational Site | Gevelsberg | |
| Germany | Boehringer Ingelheim Investigational Site | Gießen | |
| Germany | Boehringer Ingelheim Investigational Site | Gifhorn | |
| Germany | Boehringer Ingelheim Investigational Site | Gilserberg | |
| Germany | Boehringer Ingelheim Investigational Site | Gladbeck | |
| Germany | Boehringer Ingelheim Investigational Site | Gleichen | |
| Germany | Boehringer Ingelheim Investigational Site | Goch | |
| Germany | Boehringer Ingelheim Investigational Site | Gochsheim | |
| Germany | Boehringer Ingelheim Investigational Site | Göllheim | |
| Germany | Boehringer Ingelheim Investigational Site | Göllingen | |
| Germany | Boehringer Ingelheim Investigational Site | Gomaringen | |
| Germany | Boehringer Ingelheim Investigational Site | Göttingen | |
| Germany | Boehringer Ingelheim Investigational Site | Grafenau | |
| Germany | Boehringer Ingelheim Investigational Site | Gransee | |
| Germany | Boehringer Ingelheim Investigational Site | Grassau | |
| Germany | Boehringer Ingelheim Investigational Site | Greiz | |
| Germany | Boehringer Ingelheim Investigational Site | Greven | |
| Germany | Boehringer Ingelheim Investigational Site | Grevesmühlen | |
| Germany | Boehringer Ingelheim Investigational Site | Griesheim | |
| Germany | Boehringer Ingelheim Investigational Site | Grömitz | |
| Germany | Boehringer Ingelheim Investigational Site | Gronau | |
| Germany | Boehringer Ingelheim Investigational Site | Groß Grönau | |
| Germany | Boehringer Ingelheim Investigational Site | Groß Quenstedt | |
| Germany | Boehringer Ingelheim Investigational Site | Groß-Zimmern | |
| Germany | Boehringer Ingelheim Investigational Site | Großalmerode | |
| Germany | Boehringer Ingelheim Investigational Site | Großbottwar | |
| Germany | Boehringer Ingelheim Investigational Site | Großefehn | |
| Germany | Boehringer Ingelheim Investigational Site | Großhabersdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Großkorbetha | |
| Germany | Boehringer Ingelheim Investigational Site | Großlangheim | |
| Germany | Boehringer Ingelheim Investigational Site | Grünbach | |
| Germany | Boehringer Ingelheim Investigational Site | Gummersbach | |
| Germany | Boehringer Ingelheim Investigational Site | Güstrow | |
| Germany | Boehringer Ingelheim Investigational Site | Haag | |
| Germany | Boehringer Ingelheim Investigational Site | Hagen | |
| Germany | Boehringer Ingelheim Investigational Site | Haigerloch | |
| Germany | Boehringer Ingelheim Investigational Site | Haldensleben | |
| Germany | Boehringer Ingelheim Investigational Site | Halle | |
| Germany | Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site | Hamm | |
| Germany | Boehringer Ingelheim Investigational Site | Hamminkeln | |
| Germany | Boehringer Ingelheim Investigational Site | Hanau | |
| Germany | Boehringer Ingelheim Investigational Site | Hanerau-Hademarschen | |
| Germany | Boehringer Ingelheim Investigational Site | Hannover | |
| Germany | Boehringer Ingelheim Investigational Site | Harpstedt | |
| Germany | Boehringer Ingelheim Investigational Site | Harsefeld | |
| Germany | Boehringer Ingelheim Investigational Site | Harsewinkel | |
| Germany | Boehringer Ingelheim Investigational Site | Haselünne | |
| Germany | Boehringer Ingelheim Investigational Site | Hattersheim | |
| Germany | Boehringer Ingelheim Investigational Site | Hattingen | |
| Germany | Boehringer Ingelheim Investigational Site | Havixbeck | |
| Germany | Boehringer Ingelheim Investigational Site | Hedersleben | |
| Germany | Boehringer Ingelheim Investigational Site | Heek | |
| Germany | Boehringer Ingelheim Investigational Site | Heide | |
| Germany | Boehringer Ingelheim Investigational Site | Heidelberg | |
| Germany | Boehringer Ingelheim Investigational Site | Heilbronn | |
| Germany | Boehringer Ingelheim Investigational Site | Heimsheim | |
| Germany | Boehringer Ingelheim Investigational Site | Heinsberg | |
| Germany | Boehringer Ingelheim Investigational Site | Hellenthal |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in IRLS total score after 12 weeks | 12 weeks | No | |
| Primary | CGI-I responder rate after 12 weeks | 12 weeks | No | |
| Primary | Time to reach maintenance dose | 12 weeks | No | |
| Primary | Change from baseline in RLS-QoL total score after 12 weeks | 12 weeks | No | |
| Secondary | Change from baseline in IRLS score after 1-4 weeks | 4 weeks | No | |
| Secondary | Change in IRLS items after 12 weeks | 12 weeks | No | |
| Secondary | Final dose distribution | 12 weeks | No | |
| Secondary | Incidence, relationship and seriousness of adverse events | 12 weeks | No | |
| Secondary | Number of premature discontinuations | 12 weeks | No |
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