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Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropinirole Extended Release (XR) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS. | 12 Weeks |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 101468/204 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 7, 2017 | |
| Reset | Feb 15, 2018 | |
| Release | Feb 21, 2018 |
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| Mesa |
| Arizona |
| 85210 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85050 | United States |
| GSK Investigational Site | Sun City | Arizona | 85351 | United States |
| GSK Investigational Site | Anaheim | California | 92801 | United States |
| GSK Investigational Site | Burlingame | California | 94010 | United States |
| GSK Investigational Site | Long Beach | California | 90806 | United States |
| GSK Investigational Site | Newport Beach | California | 92660 | United States |
| GSK Investigational Site | Pasadena | California | 91106 | United States |
| GSK Investigational Site | Redondo Beach | California | 90277 | United States |
| GSK Investigational Site | Santa Monica | California | 90404 | United States |
| GSK Investigational Site | Stanford | California | 94305-5548 | United States |
| GSK Investigational Site | Winnetka | California | 91306 | United States |
| GSK Investigational Site | Boca Raton | Florida | 33486 | United States |
| GSK Investigational Site | Coeur d'Alene | Idaho | 83814 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01104 | United States |
| GSK Investigational Site | West Yarmouth | Massachusetts | 02673 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 01655 | United States |
| GSK Investigational Site | Kalamazoo | Michigan | 49048 | United States |
| GSK Investigational Site | Saint Paul | Minnesota | 55101 | United States |
| GSK Investigational Site | St Louis | Missouri | 63128 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Albany | New York | 12205 | United States |
| GSK Investigational Site | Tabor City | North Carolina | 28463 | United States |
| GSK Investigational Site | Fargo | North Dakota | 58104 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | United States |
| GSK Investigational Site | Burlington | Vermont | 05401 | United States |
| GSK Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| GSK Investigational Site | Auchenflower | Queensland | 4066 | Australia |
| GSK Investigational Site | Kippa-Ring | Queensland | 4021 | Australia |
| GSK Investigational Site | Innsbruck | A-6020 | Austria |
| GSK Investigational Site | Vienna | A-1090 | Austria |
| GSK Investigational Site | Brussels | 1190 | Belgium |
| GSK Investigational Site | Charleroi | 6000 | Belgium |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Glostrup Municipality | 2600 | Denmark |
| GSK Investigational Site | Hvidovre | 2650 | Denmark |
| GSK Investigational Site | Koebenhavn NV | 2300 | Denmark |
| GSK Investigational Site | Odense C | DK-5000 | Denmark |
| GSK Investigational Site | Anzin | 59410 | France |
| GSK Investigational Site | Bordeaux | 33000 | France |
| GSK Investigational Site | Bron | 69677 | France |
| GSK Investigational Site | Créteil | 94010 | France |
| GSK Investigational Site | Grenoble | 38043 | France |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Montbrison | 42600 | France |
| GSK Investigational Site | Nancy | 54035 | France |
| GSK Investigational Site | Pessac | 33604 | France |
| GSK Investigational Site | Munich | Bavaria | 80331 | Germany |
| GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19053 | Germany |
| GSK Investigational Site | Chemnitz | Saxony | 09111 | Germany |
| GSK Investigational Site | Köthen | Saxony-Anhalt | 06366 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12163 | Germany |
| GSK Investigational Site | Gera | Thuringia | 07551 | Germany |
| GSK Investigational Site | Bologna | Emilia-Romagna | 40123 | Italy |
| GSK Investigational Site | Rome | Lazio | 00168 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Pavia | Lombardy | 27100 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56126 | Italy |
| GSK Investigational Site | Amsterdam | 1066 EC | Netherlands |
| GSK Investigational Site | Geldermalsen | 4191 AH | Netherlands |
| GSK Investigational Site | Grubbenvorst | 5971 BB | Netherlands |
| GSK Investigational Site | Hoogwoud | 1718 BG | Netherlands |
| GSK Investigational Site | Nieuwegein | 3435 CM | Netherlands |
| GSK Investigational Site | Roelofarendsveen | 2371 RB | Netherlands |
| GSK Investigational Site | Zwolle | 8025 BV | Netherlands |
| GSK Investigational Site | Bergen | 5094 | Norway |
| GSK Investigational Site | Oslo | 0277 | Norway |
| GSK Investigational Site | Sandvika | N-1338 | Norway |
| GSK Investigational Site | Barcelona | 08017 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Granada | 18013 | Spain |
| GSK Investigational Site | Madrid | 28036 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07014 | Spain |
| GSK Investigational Site | San Sebastián | 20014 | Spain |
| GSK Investigational Site | Zaragoza | 50009 | Spain |
| GSK Investigational Site | Gothenburg | SE-412 55 | Sweden |
| GSK Investigational Site | Gothenburg | SE-413 45 | Sweden |
| GSK Investigational Site | Helsingborg | SE-252 21 | Sweden |
| GSK Investigational Site | Örebro | 701 85 | Sweden |
| GSK Investigational Site | Chesterfield | Derbyshire | S40 4TF | United Kingdom |
| GSK Investigational Site | Blackpool | Lancashire | FY4 3AD | United Kingdom |
| GSK Investigational Site | Frome | Somerset | BA11 1EZ | United Kingdom |
| GSK Investigational Site | Coventry | Warwickshire | CV6 4DD | United Kingdom |
| GSK Investigational Site | Trowbridge | Wiltshire | BA14 9AR | United Kingdom |
| GSK Investigational Site | Corsham | SN13 8NA | United Kingdom |
| GSK Investigational Site | Doncaster | DN1 2EG | United Kingdom |
| GSK Investigational Site | Ledbury | HR8 2DX | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/204 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/204 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/204 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/204 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/204 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/204 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 7, 2017 | Feb 15, 2018 | |||
| Feb 21, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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