Clinical trials in restless legs syndrome—Recommendations of the European RLS Study Group (EURLSSG)
Identifieur interne : 002F53 ( Main/Exploration ); précédent : 002F52; suivant : 002F54Clinical trials in restless legs syndrome—Recommendations of the European RLS Study Group (EURLSSG)
Auteurs : Claudia Trenkwalder [Allemagne] ; Ralf Kohnen [Allemagne] ; Richard P. Allen [États-Unis] ; Heike Benes [Allemagne] ; Luigi Ferini-Strambi [Italie] ; Diego Garcia-Borreguero [Espagne] ; Georgios M. Hadjigeorgiou [Grèce] ; Svenja Happe ; Birgit Högl [Autriche] ; Magdolna Hornyak [Allemagne] ; Christine Klein [Allemagne] ; Alexander Nass [Allemagne] ; Pasquale Montagna [Italie] ; Wolfgang H. Oertel [Allemagne] ; Shaun O'Keeffe [Irlande (pays)] ; Walter Paulus [Allemagne] ; Werner Poewe [Autriche] ; Federica Provini [Italie] ; Peter P. Pramstaller [Italie] ; Mariusz Sieminski [Pologne] ; Karel Sonka [République tchèque] ; Karin Stiasny-Kolster [Allemagne] ; Al De Weerd [Pays-Bas] ; Thomas C. Wetter [Allemagne] ; Juliane Winkelmann [Allemagne] ; Marco Zucconi [Italie]Source :
- Movement Disorders [ 0885-3185 ] ; 2007.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Recommandation.
English descriptors
- KwdEn :
- Clinical trial, Diagnosis, Endpoint Determination, Europe, Humans, Nervous system diseases, Patient Selection, Polysomnography, Randomized Controlled Trials as Topic, Recommendation, Restless Legs Syndrome (complications), Restless Legs Syndrome (diagnosis), Restless Legs Syndrome (drug therapy), Restless legs syndrome, Treatment, Treatment Outcome, clinical trial, consensus, diagnosis, restless legs syndrome, therapy.
- MESH :
- geographic : Europe.
- complications : Restless Legs Syndrome.
- diagnosis : Restless Legs Syndrome.
- drug therapy : Restless Legs Syndrome.
- Endpoint Determination, Humans, Patient Selection, Polysomnography, Randomized Controlled Trials as Topic, Treatment Outcome.
Abstract
The European Restless Legs Syndrome (RLS) Study Group (EURLSSG) is an association of European RLS experts who are actively involved in RLS research. A major aim of the Study Group is the development and continuous improvement of standards for diagnosis and treatment of RLS. Several members developed study designs and evaluation methods in investigator‐initiated trials early in the 1990s, and all members have since contributed to many pivotal and nonpivotal drug trials for the treatment of RLS. The recommendations on clinical investigations of pharmacological treatment of RLS patients summarize the group's expertise and knowledge acquired through clinical trials. The recommendations primarily address how to plan and conduct confirmatory, randomized clinical studies in patients with idiopathic RLS. Advice is presented for the diagnosis of RLS and clinical and polysomnographic inclusion and exclusion criteria. Primary and secondary endpoints for an evaluation of efficacy are based on a critical description of validated methods for both short‐ and long‐term trials, also in special populations (children, pregnant women, elderly patients). The recommendations include the assessment of augmentation. Finally, general issues including the evaluation of safety and tolerability, as well as specific neurological and cardiovascular risks and sleep attacks/daytime somnolence, are discussed. The aim of these recommendations is to support research groups or pharmaceutical companies in the design of optimized study protocols. © 2007 Movement Disorder Society
Url:
DOI: 10.1002/mds.21538
Affiliations:
- Allemagne, Autriche, Espagne, Grèce, Irlande (pays), Italie, Pays-Bas, Pologne, République tchèque, États-Unis
- Bade-Wurtemberg, Bavière, Bohême centrale, Communauté de Madrid, District de Fribourg-en-Brisgau, District de Giessen, District de Haute-Bavière, District de Kassel, Hesse (Land), Maryland, Tyrol (Land)
- Cassel (Hesse), Fribourg-en-Brisgau, Innsbruck, Madrid, Marbourg, Munich, Prague
- Université de médecine d'Innsbruck
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Le document en format XML
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Hadjigeorgiou</name><affiliation wicri:level="1"><country xml:lang="fr">Grèce</country><wicri:regionArea>Department of Neurology, University of Thessaly, Larissa</wicri:regionArea><wicri:noRegion>Larissa</wicri:noRegion></affiliation></author><author><name sortKey="Happe, Svenja" sort="Happe, Svenja" uniqKey="Happe S" first="Svenja" last="Happe">Svenja Happe</name><affiliation><wicri:noCountry code="subField">Bremen</wicri:noCountry></affiliation></author><author><name sortKey="Hogl, Birgit" sort="Hogl, Birgit" uniqKey="Hogl B" first="Birgit" last="Högl">Birgit Högl</name><affiliation wicri:level="1"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Innsbruck Medical University, Innsbruck</wicri:regionArea><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Hornyak, Magdolna" sort="Hornyak, Magdolna" uniqKey="Hornyak M" first="Magdolna" last="Hornyak">Magdolna Hornyak</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Psychiatry, University of Freiburg, Freiburg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Fribourg-en-Brisgau</region><settlement type="city">Fribourg-en-Brisgau</settlement></placeName></affiliation></author><author><name sortKey="Klein, Christine" sort="Klein, Christine" uniqKey="Klein C" first="Christine" last="Klein">Christine Klein</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Neurology Department, University of Luebeck, Luebeck</wicri:regionArea><wicri:noRegion>Luebeck</wicri:noRegion><wicri:noRegion>Luebeck</wicri:noRegion></affiliation></author><author><name sortKey="Nass, Alexander" sort="Nass, Alexander" uniqKey="Nass A" first="Alexander" last="Nass">Alexander Nass</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Private Practice, Cologne</wicri:regionArea><wicri:noRegion>Cologne</wicri:noRegion><wicri:noRegion>Cologne</wicri:noRegion></affiliation></author><author><name sortKey="Montagna, Pasquale" sort="Montagna, Pasquale" uniqKey="Montagna P" first="Pasquale" last="Montagna">Pasquale Montagna</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurological Sciences, University of Bologna, Bologna</wicri:regionArea><wicri:noRegion>Bologna</wicri:noRegion></affiliation></author><author><name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H" last="Oertel">Wolfgang H. Oertel</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, University of Marburg, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="O Keeffe, Shaun" sort="O Keeffe, Shaun" uniqKey="O Keeffe S" first="Shaun" last="O'Keeffe">Shaun O'Keeffe</name><affiliation wicri:level="1"><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Merlin Park Regional Hospital, Galway</wicri:regionArea><wicri:noRegion>Galway</wicri:noRegion></affiliation></author><author><name sortKey="Paulus, Walter" sort="Paulus, Walter" uniqKey="Paulus W" first="Walter" last="Paulus">Walter Paulus</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Clinical Neurophysiology, University of Goettingen, Goettingen</wicri:regionArea><wicri:noRegion>Goettingen</wicri:noRegion><wicri:noRegion>Goettingen</wicri:noRegion></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Innsbruck Medical University, Innsbruck</wicri:regionArea><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Provini, Federica" sort="Provini, Federica" uniqKey="Provini F" first="Federica" last="Provini">Federica Provini</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurological Sciences, University of Bologna, Bologna</wicri:regionArea><wicri:noRegion>Bologna</wicri:noRegion></affiliation></author><author><name sortKey="Pramstaller, Peter P" sort="Pramstaller, Peter P" uniqKey="Pramstaller P" first="Peter P." last="Pramstaller">Peter P. Pramstaller</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurology, Central Hospital and Institute of Genetic Medicine, EURAC‐Research, Bolzano‐Bozen</wicri:regionArea><wicri:noRegion>Bolzano‐Bozen</wicri:noRegion></affiliation></author><author><name sortKey="Sieminski, Mariusz" sort="Sieminski, Mariusz" uniqKey="Sieminski M" first="Mariusz" last="Sieminski">Mariusz Sieminski</name><affiliation wicri:level="1"><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Adults' Neurology, Medical Unversity of Gdansk</wicri:regionArea><wicri:noRegion>Medical Unversity of Gdansk</wicri:noRegion></affiliation></author><author><name sortKey="Sonka, Karel" sort="Sonka, Karel" uniqKey="Sonka K" first="Karel" last="Sonka">Karel Sonka</name><affiliation wicri:level="3"><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Neurology, Charles University, Prague</wicri:regionArea><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Stiasny Olster, Karin" sort="Stiasny Olster, Karin" uniqKey="Stiasny Olster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, University of Marburg, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="De Weerd, Al" sort="De Weerd, Al" uniqKey="De Weerd A" first="Al" last="De Weerd">Al De Weerd</name><affiliation wicri:level="1"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Sleep Center SEIN Zwolle, Zwolle</wicri:regionArea><wicri:noRegion>Zwolle</wicri:noRegion></affiliation></author><author><name sortKey="Wetter, Thomas C" sort="Wetter, Thomas C" uniqKey="Wetter T" first="Thomas C." last="Wetter">Thomas C. Wetter</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Max‐Planck Institute of Psychiatry, Munich</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement></placeName></affiliation></author><author><name sortKey="Winkelmann, Juliane" sort="Winkelmann, Juliane" uniqKey="Winkelmann J" first="Juliane" last="Winkelmann">Juliane Winkelmann</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Max‐Planck Institute of Psychiatry, Munich</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement></placeName></affiliation></author><author><name sortKey="Zucconi, Marco" sort="Zucconi, Marco" uniqKey="Zucconi M" first="Marco" last="Zucconi">Marco Zucconi</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Sleep Disorders Center, University Vita‐Salute San Raffaele, Milano</wicri:regionArea><wicri:noRegion>Milano</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007">2007</date><biblScope unit="vol">22</biblScope><biblScope unit="issue">S18</biblScope><biblScope unit="supplement">S18</biblScope><biblScope unit="page" from="S495">S495</biblScope><biblScope unit="page" to="S504">S504</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">D503E31A7C89305AC8F2BC78A69A6487A7BD686F</idno><idno type="DOI">10.1002/mds.21538</idno><idno type="ArticleID">MDS21538</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical trial</term><term>Diagnosis</term><term>Endpoint Determination</term><term>Europe</term><term>Humans</term><term>Nervous system diseases</term><term>Patient Selection</term><term>Polysomnography</term><term>Randomized Controlled Trials as Topic</term><term>Recommendation</term><term>Restless Legs Syndrome (complications)</term><term>Restless Legs Syndrome (diagnosis)</term><term>Restless Legs Syndrome (drug therapy)</term><term>Restless legs syndrome</term><term>Treatment</term><term>Treatment Outcome</term><term>clinical trial</term><term>consensus</term><term>diagnosis</term><term>restless legs syndrome</term><term>therapy</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Europe</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Endpoint Determination</term><term>Humans</term><term>Patient Selection</term><term>Polysomnography</term><term>Randomized Controlled Trials as Topic</term><term>Treatment Outcome</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Diagnostic</term><term>Essai clinique</term><term>Pathologie du système nerveux</term><term>Recommandation</term><term>Syndrome des jambes sans repos</term><term>Traitement</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Recommandation</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The European Restless Legs Syndrome (RLS) Study Group (EURLSSG) is an association of European RLS experts who are actively involved in RLS research. A major aim of the Study Group is the development and continuous improvement of standards for diagnosis and treatment of RLS. Several members developed study designs and evaluation methods in investigator‐initiated trials early in the 1990s, and all members have since contributed to many pivotal and nonpivotal drug trials for the treatment of RLS. The recommendations on clinical investigations of pharmacological treatment of RLS patients summarize the group's expertise and knowledge acquired through clinical trials. The recommendations primarily address how to plan and conduct confirmatory, randomized clinical studies in patients with idiopathic RLS. Advice is presented for the diagnosis of RLS and clinical and polysomnographic inclusion and exclusion criteria. Primary and secondary endpoints for an evaluation of efficacy are based on a critical description of validated methods for both short‐ and long‐term trials, also in special populations (children, pregnant women, elderly patients). The recommendations include the assessment of augmentation. Finally, general issues including the evaluation of safety and tolerability, as well as specific neurological and cardiovascular risks and sleep attacks/daytime somnolence, are discussed. The aim of these recommendations is to support research groups or pharmaceutical companies in the design of optimized study protocols. © 2007 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Autriche</li><li>Espagne</li><li>Grèce</li><li>Irlande (pays)</li><li>Italie</li><li>Pays-Bas</li><li>Pologne</li><li>République tchèque</li><li>États-Unis</li></country><region><li>Bade-Wurtemberg</li><li>Bavière</li><li>Bohême centrale</li><li>Communauté de Madrid</li><li>District de Fribourg-en-Brisgau</li><li>District de Giessen</li><li>District de Haute-Bavière</li><li>District de Kassel</li><li>Hesse (Land)</li><li>Maryland</li><li>Tyrol (Land)</li></region><settlement><li>Cassel (Hesse)</li><li>Fribourg-en-Brisgau</li><li>Innsbruck</li><li>Madrid</li><li>Marbourg</li><li>Munich</li><li>Prague</li></settlement><orgName><li>Université de médecine d'Innsbruck</li></orgName></list><tree><noCountry><name sortKey="Happe, Svenja" sort="Happe, Svenja" uniqKey="Happe S" first="Svenja" last="Happe">Svenja Happe</name></noCountry><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name></region><name sortKey="Benes, Heike" sort="Benes, Heike" uniqKey="Benes H" first="Heike" last="Benes">Heike Benes</name><name sortKey="Benes, Heike" sort="Benes, Heike" uniqKey="Benes H" first="Heike" last="Benes">Heike Benes</name><name sortKey="Hornyak, Magdolna" sort="Hornyak, Magdolna" uniqKey="Hornyak M" first="Magdolna" last="Hornyak">Magdolna Hornyak</name><name sortKey="Klein, Christine" sort="Klein, Christine" uniqKey="Klein C" first="Christine" last="Klein">Christine Klein</name><name sortKey="Kohnen, Ralf" sort="Kohnen, Ralf" uniqKey="Kohnen R" first="Ralf" last="Kohnen">Ralf Kohnen</name><name sortKey="Nass, Alexander" sort="Nass, Alexander" uniqKey="Nass A" first="Alexander" last="Nass">Alexander Nass</name><name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H" last="Oertel">Wolfgang H. Oertel</name><name sortKey="Paulus, Walter" sort="Paulus, Walter" uniqKey="Paulus W" first="Walter" last="Paulus">Walter Paulus</name><name sortKey="Stiasny Olster, Karin" sort="Stiasny Olster, Karin" uniqKey="Stiasny Olster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name><name sortKey="Wetter, Thomas C" sort="Wetter, Thomas C" uniqKey="Wetter T" first="Thomas C." last="Wetter">Thomas C. Wetter</name><name sortKey="Winkelmann, Juliane" sort="Winkelmann, Juliane" uniqKey="Winkelmann J" first="Juliane" last="Winkelmann">Juliane Winkelmann</name></country><country name="États-Unis"><region name="Maryland"><name sortKey="Allen, Richard P" sort="Allen, Richard P" uniqKey="Allen R" first="Richard P." last="Allen">Richard P. Allen</name></region></country><country name="Italie"><noRegion><name sortKey="Ferini Trambi, Luigi" sort="Ferini Trambi, Luigi" uniqKey="Ferini Trambi L" first="Luigi" last="Ferini-Strambi">Luigi Ferini-Strambi</name></noRegion><name sortKey="Montagna, Pasquale" sort="Montagna, Pasquale" uniqKey="Montagna P" first="Pasquale" last="Montagna">Pasquale Montagna</name><name sortKey="Pramstaller, Peter P" sort="Pramstaller, Peter P" uniqKey="Pramstaller P" first="Peter P." last="Pramstaller">Peter P. Pramstaller</name><name sortKey="Provini, Federica" sort="Provini, Federica" uniqKey="Provini F" first="Federica" last="Provini">Federica Provini</name><name sortKey="Zucconi, Marco" sort="Zucconi, Marco" uniqKey="Zucconi M" first="Marco" last="Zucconi">Marco Zucconi</name></country><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Garcia Orreguero, Diego" sort="Garcia Orreguero, Diego" uniqKey="Garcia Orreguero D" first="Diego" last="Garcia-Borreguero">Diego Garcia-Borreguero</name></region></country><country name="Grèce"><noRegion><name sortKey="Hadjigeorgiou, Georgios M" sort="Hadjigeorgiou, Georgios M" uniqKey="Hadjigeorgiou G" first="Georgios M." last="Hadjigeorgiou">Georgios M. Hadjigeorgiou</name></noRegion></country><country name="Autriche"><noRegion><name sortKey="Hogl, Birgit" sort="Hogl, Birgit" uniqKey="Hogl B" first="Birgit" last="Högl">Birgit Högl</name></noRegion><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></country><country name="Irlande (pays)"><noRegion><name sortKey="O Keeffe, Shaun" sort="O Keeffe, Shaun" uniqKey="O Keeffe S" first="Shaun" last="O'Keeffe">Shaun O'Keeffe</name></noRegion></country><country name="Pologne"><noRegion><name sortKey="Sieminski, Mariusz" sort="Sieminski, Mariusz" uniqKey="Sieminski M" first="Mariusz" last="Sieminski">Mariusz Sieminski</name></noRegion></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Sonka, Karel" sort="Sonka, Karel" uniqKey="Sonka K" first="Karel" last="Sonka">Karel Sonka</name></region></country><country name="Pays-Bas"><noRegion><name sortKey="De Weerd, Al" sort="De Weerd, Al" uniqKey="De Weerd A" first="Al" last="De Weerd">Al De Weerd</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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