Rotigotine improves restless legs syndrome: A 6‐month randomized, double‐blind, placebo‐controlled trial in the United States
Identifieur interne : 001A22 ( Main/Exploration ); précédent : 001A21; suivant : 001A23Rotigotine improves restless legs syndrome: A 6‐month randomized, double‐blind, placebo‐controlled trial in the United States
Auteurs : Wayne A. Hening [États-Unis] ; Richard P. Allen [États-Unis] ; William G. Ondo [États-Unis] ; Arthur S. Walters [États-Unis] ; John W. Winkelman [États-Unis] ; Philip Becker [États-Unis] ; Richard Bogan [États-Unis] ; June M. Fry [États-Unis] ; David B. Kudrow [États-Unis] ; Kurt W. Lesh [États-Unis] ; Andreas Fichtner [Allemagne] ; Erwin Schollmayer [Allemagne]Source :
- Movement Disorders [ 0885-3185 ] ; 2010-08-15.
Descripteurs français
- Pascal (Inist)
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Dopamine Agonists (therapeutic use), Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Nervous system diseases, Placebo, Restless Legs Syndrome (drug therapy), Restless legs syndrome, Rotigotine, Severity of Illness Index, Tetrahydronaphthalenes (therapeutic use), Thiophenes (therapeutic use), Transdermal Patch, Treatment Outcome, United States, United States (epidemiology), Young Adult, daytime/nighttime symptoms, dopamine agonist, quality of life, restless legs syndrome, rotigotine transdermal patch.
- MESH :
- chemical , therapeutic use : Dopamine Agonists, Tetrahydronaphthalenes, Thiophenes.
- geographic , epidemiology : United States.
- drug therapy : Restless Legs Syndrome.
- Adolescent, Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index, Transdermal Patch, Treatment Outcome, Young Adult.
Abstract
This randomized, double‐blinded, placebo‐controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6‐month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score ≥ 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once‐daily transdermal patch (fixed‐dose regimen). The two co‐primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI‐1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were −4.5 (95% CI: −6.9, −2.2) for 2 mg/24 hr rotigotine, −5.2 (95% CI: −7.5, −2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 −0.65 (95% CI: −1.0, −0.3) and −0.9 (95% CI: −1.3, −0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6‐month double‐blind period. © 2010 Movement Disorder Society
Url:
DOI: 10.1002/mds.23157
Affiliations:
- Allemagne, États-Unis
- Californie, Caroline du Sud, Colorado, Maryland, Massachusetts, New Jersey, Pennsylvanie, Tennessee, Texas
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 000389
- to stream Istex, to step Curation: 000389
- to stream Istex, to step Checkpoint: 000701
- to stream PubMed, to step Corpus: 001762
- to stream PubMed, to step Curation: 001762
- to stream PubMed, to step Checkpoint: 001628
- to stream Ncbi, to step Merge: 002C55
- to stream Ncbi, to step Curation: 002C55
- to stream Ncbi, to step Checkpoint: 002C55
- to stream Main, to step Merge: 001E58
- to stream PascalFrancis, to step Corpus: 000948
- to stream PascalFrancis, to step Curation: 002371
- to stream PascalFrancis, to step Checkpoint: 000850
- to stream Main, to step Merge: 002437
- to stream Main, to step Curation: 001A22
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Rotigotine improves restless legs syndrome: A 6‐month randomized, double‐blind, placebo‐controlled trial in the United States</title><author><name sortKey="Hening, Wayne A" sort="Hening, Wayne A" uniqKey="Hening W" first="Wayne A." last="Hening">Wayne A. Hening</name></author><author><name sortKey="Allen, Richard P" sort="Allen, Richard P" uniqKey="Allen R" first="Richard P." last="Allen">Richard P. Allen</name></author><author><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G." last="Ondo">William G. Ondo</name></author><author><name sortKey="Walters, Arthur S" sort="Walters, Arthur S" uniqKey="Walters A" first="Arthur S." last="Walters">Arthur S. Walters</name></author><author><name sortKey="Winkelman, John W" sort="Winkelman, John W" uniqKey="Winkelman J" first="John W." last="Winkelman">John W. Winkelman</name></author><author><name sortKey="Becker, Philip" sort="Becker, Philip" uniqKey="Becker P" first="Philip" last="Becker">Philip Becker</name></author><author><name sortKey="Bogan, Richard" sort="Bogan, Richard" uniqKey="Bogan R" first="Richard" last="Bogan">Richard Bogan</name></author><author><name sortKey="Fry, June M" sort="Fry, June M" uniqKey="Fry J" first="June M." last="Fry">June M. Fry</name></author><author><name sortKey="Kudrow, David B" sort="Kudrow, David B" uniqKey="Kudrow D" first="David B." last="Kudrow">David B. Kudrow</name></author><author><name sortKey="Lesh, Kurt W" sort="Lesh, Kurt W" uniqKey="Lesh K" first="Kurt W." last="Lesh">Kurt W. Lesh</name></author><author><name sortKey="Fichtner, Andreas" sort="Fichtner, Andreas" uniqKey="Fichtner A" first="Andreas" last="Fichtner">Andreas Fichtner</name></author><author><name sortKey="Schollmayer, Erwin" sort="Schollmayer, Erwin" uniqKey="Schollmayer E" first="Erwin" last="Schollmayer">Erwin Schollmayer</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:38245043EA609F264B40A03A64950B197A892A0D</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1002/mds.23157</idno><idno type="url">https://api.istex.fr/document/38245043EA609F264B40A03A64950B197A892A0D/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000389</idno><idno type="wicri:Area/Istex/Curation">000389</idno><idno type="wicri:Area/Istex/Checkpoint">000701</idno><idno type="wicri:doubleKey">0885-3185:2010:Hening W:rotigotine:improves:restless</idno><idno type="wicri:source">PubMed</idno><idno type="RBID">pubmed:20629075</idno><idno type="wicri:Area/PubMed/Corpus">001762</idno><idno type="wicri:Area/PubMed/Curation">001762</idno><idno type="wicri:Area/PubMed/Checkpoint">001628</idno><idno type="wicri:Area/Ncbi/Merge">002C55</idno><idno type="wicri:Area/Ncbi/Curation">002C55</idno><idno type="wicri:Area/Ncbi/Checkpoint">002C55</idno><idno type="wicri:Area/Main/Merge">001E58</idno><idno type="wicri:source">INIST</idno><idno type="RBID">Pascal:10-0413291</idno><idno type="wicri:Area/PascalFrancis/Corpus">000948</idno><idno type="wicri:Area/PascalFrancis/Curation">002371</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000850</idno><idno type="wicri:doubleKey">0885-3185:2010:Hening W:rotigotine:improves:restless</idno><idno type="wicri:Area/Main/Merge">002437</idno><idno type="wicri:Area/Main/Curation">001A22</idno><idno type="wicri:Area/Main/Exploration">001A22</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Rotigotine improves restless legs syndrome: A 6‐month randomized, double‐blind, placebo‐controlled trial in the United States</title><author><name sortKey="Hening, Wayne A" sort="Hening, Wayne A" uniqKey="Hening W" first="Wayne A." last="Hening">Wayne A. Hening</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, UMDNJ‐Robert Wood Johnson Medical School, New Brunswick, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Allen, Richard P" sort="Allen, Richard P" uniqKey="Allen R" first="Richard P." last="Allen">Richard P. Allen</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology and Sleep Medicine, John Hopkins University, Baltimore, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G." last="Ondo">William G. Ondo</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Baylor College of Medicine, Houston, Texas</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Walters, Arthur S" sort="Walters, Arthur S" uniqKey="Walters A" first="Arthur S." last="Walters">Arthur S. Walters</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Winkelman, John W" sort="Winkelman, John W" uniqKey="Winkelman J" first="John W." last="Winkelman">John W. Winkelman</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Sleep Health Center, Brigham and Women's Hospital, Harvard Medical School, Brighton, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Becker, Philip" sort="Becker, Philip" uniqKey="Becker P" first="Philip" last="Becker">Philip Becker</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Texas</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Bogan, Richard" sort="Bogan, Richard" uniqKey="Bogan R" first="Richard" last="Bogan">Richard Bogan</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of South Carolina, Columbia, South Carolina</wicri:regionArea><placeName><region type="state">Caroline du Sud</region></placeName></affiliation></author><author><name sortKey="Fry, June M" sort="Fry, June M" uniqKey="Fry J" first="June M." last="Fry">June M. Fry</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Director, Center for Sleep Medicine, Lafayette Hill, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Kudrow, David B" sort="Kudrow, David B" uniqKey="Kudrow D" first="David B." last="Kudrow">David B. Kudrow</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Neurological Research Institute, Santa Monica, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Lesh, Kurt W" sort="Lesh, Kurt W" uniqKey="Lesh K" first="Kurt W." last="Lesh">Kurt W. Lesh</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Lynn Institute of the Rockies, Colorado Springs, Colorado</wicri:regionArea><placeName><region type="state">Colorado</region></placeName></affiliation></author><author><name sortKey="Fichtner, Andreas" sort="Fichtner, Andreas" uniqKey="Fichtner A" first="Andreas" last="Fichtner">Andreas Fichtner</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Schwarz Biosciences GmbH, UCB Group, Monheim</wicri:regionArea><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>Monheim</wicri:noRegion></affiliation></author><author><name sortKey="Schollmayer, Erwin" sort="Schollmayer, Erwin" uniqKey="Schollmayer E" first="Erwin" last="Schollmayer">Erwin Schollmayer</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Schwarz Biosciences GmbH, UCB Group, Monheim</wicri:regionArea><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>Monheim</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</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="2010-08-15">2010-08-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1675">1675</biblScope><biblScope unit="page" to="1683">1683</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">38245043EA609F264B40A03A64950B197A892A0D</idno><idno type="DOI">10.1002/mds.23157</idno><idno type="ArticleID">MDS23157</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Dopamine Agonists (therapeutic use)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Placebo</term><term>Restless Legs Syndrome (drug therapy)</term><term>Restless legs syndrome</term><term>Rotigotine</term><term>Severity of Illness Index</term><term>Tetrahydronaphthalenes (therapeutic use)</term><term>Thiophenes (therapeutic use)</term><term>Transdermal Patch</term><term>Treatment Outcome</term><term>United States</term><term>United States (epidemiology)</term><term>Young Adult</term><term>daytime/nighttime symptoms</term><term>dopamine agonist</term><term>quality of life</term><term>restless legs syndrome</term><term>rotigotine transdermal patch</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Dopamine Agonists</term><term>Tetrahydronaphthalenes</term><term>Thiophenes</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term><term>Transdermal Patch</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Etats-Unis</term><term>Pathologie du système nerveux</term><term>Placebo</term><term>Rotigotine</term><term>Syndrome des jambes sans repos</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This randomized, double‐blinded, placebo‐controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6‐month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score ≥ 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once‐daily transdermal patch (fixed‐dose regimen). The two co‐primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI‐1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were −4.5 (95% CI: −6.9, −2.2) for 2 mg/24 hr rotigotine, −5.2 (95% CI: −7.5, −2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 −0.65 (95% CI: −1.0, −0.3) and −0.9 (95% CI: −1.3, −0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6‐month double‐blind period. © 2010 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>États-Unis</li></country><region><li>Californie</li><li>Caroline du Sud</li><li>Colorado</li><li>Maryland</li><li>Massachusetts</li><li>New Jersey</li><li>Pennsylvanie</li><li>Tennessee</li><li>Texas</li></region></list><tree><country name="États-Unis"><region name="New Jersey"><name sortKey="Hening, Wayne A" sort="Hening, Wayne A" uniqKey="Hening W" first="Wayne A." last="Hening">Wayne A. Hening</name></region><name sortKey="Allen, Richard P" sort="Allen, Richard P" uniqKey="Allen R" first="Richard P." last="Allen">Richard P. Allen</name><name sortKey="Becker, Philip" sort="Becker, Philip" uniqKey="Becker P" first="Philip" last="Becker">Philip Becker</name><name sortKey="Bogan, Richard" sort="Bogan, Richard" uniqKey="Bogan R" first="Richard" last="Bogan">Richard Bogan</name><name sortKey="Fry, June M" sort="Fry, June M" uniqKey="Fry J" first="June M." last="Fry">June M. Fry</name><name sortKey="Kudrow, David B" sort="Kudrow, David B" uniqKey="Kudrow D" first="David B." last="Kudrow">David B. Kudrow</name><name sortKey="Lesh, Kurt W" sort="Lesh, Kurt W" uniqKey="Lesh K" first="Kurt W." last="Lesh">Kurt W. Lesh</name><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G." last="Ondo">William G. Ondo</name><name sortKey="Walters, Arthur S" sort="Walters, Arthur S" uniqKey="Walters A" first="Arthur S." last="Walters">Arthur S. Walters</name><name sortKey="Winkelman, John W" sort="Winkelman, John W" uniqKey="Winkelman J" first="John W." last="Winkelman">John W. Winkelman</name></country><country name="Allemagne"><noRegion><name sortKey="Fichtner, Andreas" sort="Fichtner, Andreas" uniqKey="Fichtner A" first="Andreas" last="Fichtner">Andreas Fichtner</name></noRegion><name sortKey="Schollmayer, Erwin" sort="Schollmayer, Erwin" uniqKey="Schollmayer E" first="Erwin" last="Schollmayer">Erwin Schollmayer</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001A22 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001A22 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:38245043EA609F264B40A03A64950B197A892A0D
|texte= Rotigotine improves restless legs syndrome: A 6‐month randomized, double‐blind, placebo‐controlled trial in the United States
}}
| This area was generated with Dilib version V0.6.23. |  |