Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome
Identifieur interne : 000224 ( Istex/Corpus ); précédent : 000223; suivant : 000225Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome
Auteurs : John W. Winkelman ; Richard K. Bogan ; Markus H. Schmidt ; John D. Hudson ; Sarah E. Derossett ; Christina E. Hill-ZabalaSource :
- Movement Disorders [ 0885-3185 ] ; 2011-09.
English descriptors
Abstract
We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome–associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. © 2011 Movement Disorder Society
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DOI: 10.1002/mds.23771
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This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome–associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. © 2011 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>John W. Winkelman MD, PhD</name><affiliations><json:string>Brigham and Women's Hospital Sleep Health Center, Brighton, Massachusetts, USA</json:string></affiliations></json:item><json:item><name>Richard K. Bogan MD</name><affiliations><json:string>SleepMed, Columbia, South Carolina, USA</json:string></affiliations></json:item><json:item><name>Markus H. Schmidt MD, PhD</name><affiliations><json:string>Ohio Sleep Medicine Institute, Dublin, Ohio, USA</json:string></affiliations></json:item><json:item><name>John D. Hudson MD</name><affiliations><json:string>FutureSearch Trials of Neurology, Austin, Texas, USA</json:string></affiliations></json:item><json:item><name>Sarah E. DeRossett MD, PhD</name><affiliations><json:string>GlaxoSmithKline, Research Triangle Park, North Carolina, USA</json:string></affiliations></json:item><json:item><name>Christina E. Hill‐Zabala PharmD</name><affiliations><json:string>GlaxoSmithKline, Research Triangle Park, North Carolina, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>gabapentin enacarbil</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>polysomnography</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>restless legs syndrome</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>sleep disturbance</value></json:item></subject><language><json:string>eng</json:string></language><abstract>We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; P > .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome–associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. © 2011 Movement Disorder Society</abstract><qualityIndicators><score>7.974</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1939</abstractCharCount><pdfWordCount>4974</pdfWordCount><pdfCharCount>31758</pdfCharCount><pdfPageCount>8</pdfPageCount><abstractWordCount>267</abstractWordCount></qualityIndicators><title>Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome</title><genre><json:string>Serial article</json:string></genre><host><volume>26</volume><pages><total>8</total><last>2072</last><first>2065</first></pages><issn><json:string>0885-3185</json:string></issn><issue>11</issue><subject><json:item><value>Research Article</value></json:item></subject><genre></genre><language><json:string>unknown</json:string></language><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2011</publicationDate><copyrightDate>2011</copyrightDate><doi><json:string>10.1002/mds.23771</json:string></doi><id>80D3C8FB34FFAA26DF8F1C26B314839720A5D8BC</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/80D3C8FB34FFAA26DF8F1C26B314839720A5D8BC/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/80D3C8FB34FFAA26DF8F1C26B314839720A5D8BC/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/80D3C8FB34FFAA26DF8F1C26B314839720A5D8BC/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Wiley Subscription Services, Inc., A Wiley Company</p></availability><date>2011</date></publicationStmt><notesStmt><note type="content">*Funding agencies: Research funding for design and conduct of this study and for collection, management, analysis, and interpretation of the data was sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina. Preparation and review of the manuscript were sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina.</note><note type="content">*Relevant conflicts of interest/financial disclosures: Dr. John Winkelman has received consulting fees from GlaxoSmithKline. Dr. Richard Bogan has received consulting fees and research funding from GlaxoSmithKline and received research funding from XenoPort, Inc. Dr. Markus Schmidt has received consulting fees and research funding from GlaxoSmithKline and received research funding from Xenoport, Inc. Dr. John Hudson has served on the Speaker's Bureau for GlaxoSmithKline and received research funding from GlaxoSmithKline and XenoPort, Inc. Drs. DeRossett and Hill‐Zabala are employees of GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Editorial assistance was provided by Sarah Brown and Phillippa Curran of Caudex Medical, Oxford, UK (funded by GlaxoSmithKline), who collated author comments. Assistance was provided with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339:b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the acknowledgments section of the manuscript.</note><note type="content">*Full financial disclosures and author roles may be found in the online version of this article.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome</title><author><persName><forename type="first">John W.</forename><surname>Winkelman</surname><roleName type="degree">MD, PhD</roleName></persName><note type="correspondence"><p>Correspondence: Brigham and Women's Hospital Sleep Health Center, 1505 Commonwealth Ave. 5th Floor, Brighton, MA 02135, USA</p></note><affiliation>Brigham and Women's Hospital Sleep Health Center, Brighton, Massachusetts, USA</affiliation></author><author><persName><forename type="first">Richard K.</forename><surname>Bogan</surname><roleName type="degree">MD</roleName></persName><affiliation>SleepMed, Columbia, South Carolina, USA</affiliation></author><author><persName><forename type="first">Markus H.</forename><surname>Schmidt</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>Ohio Sleep Medicine Institute, Dublin, Ohio, USA</affiliation></author><author><persName><forename type="first">John D.</forename><surname>Hudson</surname><roleName type="degree">MD</roleName></persName><affiliation>FutureSearch Trials of Neurology, Austin, Texas, USA</affiliation></author><author><persName><forename type="first">Sarah E.</forename><surname>DeRossett</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>GlaxoSmithKline, Research Triangle Park, North Carolina, USA</affiliation></author><author><persName><forename type="first">Christina E.</forename><surname>Hill‐Zabala</surname><roleName type="degree">PharmD</roleName></persName><affiliation>GlaxoSmithKline, Research Triangle Park, North Carolina, USA</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. 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This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). 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Sleep Health Center, Brighton, Massachusetts, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>SleepMed, Columbia, South Carolina, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Ohio Sleep Medicine Institute, Dublin, Ohio, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>FutureSearch Trials of Neurology, Austin, Texas, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>GlaxoSmithKline, Research Triangle Park, North Carolina, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">gabapentin enacarbil</keyword><keyword xml:id="kwd2">polysomnography</keyword><keyword xml:id="kwd3">restless legs syndrome</keyword><keyword xml:id="kwd4">sleep disturbance</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; <i>P</i> < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; <i>P</i> = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome–associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. © 2011 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn14"><p><b>Funding agencies:</b> Research funding for design and conduct of this study and for collection, management, analysis, and interpretation of the data was sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina. Preparation and review of the manuscript were sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina.</p></note><note xml:id="fn15"><p><b>Relevant conflicts of interest/financial disclosures:</b> Dr. John Winkelman has received consulting fees from GlaxoSmithKline. Dr. Richard Bogan has received consulting fees and research funding from GlaxoSmithKline and received research funding from XenoPort, Inc. Dr. Markus Schmidt has received consulting fees and research funding from GlaxoSmithKline and received research funding from Xenoport, Inc. Dr. John Hudson has served on the Speaker's Bureau for GlaxoSmithKline and received research funding from GlaxoSmithKline and XenoPort, Inc. Drs. DeRossett and Hill‐Zabala are employees of GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Editorial assistance was provided by Sarah Brown and Phillippa Curran of Caudex Medical, Oxford, UK (funded by GlaxoSmithKline), who collated author comments. Assistance was provided with full consent of the authors and in compliance with Good Publication Practice 2 (<i>BMJ</i> 2009;339:b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the acknowledgments section of the manuscript.</p></note><note xml:id="fn16"><p>Full financial disclosures and author roles may be found in the online version of this article.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 4-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>PSG Study of Gabapentin Enacarbil in RLS</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome</title></titleInfo><name type="personal"><namePart type="given">John W.</namePart><namePart type="family">Winkelman</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Brigham and Women's Hospital Sleep Health Center, Brighton, Massachusetts, USA</affiliation><description>Correspondence: Brigham and Women's Hospital Sleep Health Center, 1505 Commonwealth Ave. 5th Floor, Brighton, MA 02135, USA</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Richard K.</namePart><namePart type="family">Bogan</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>SleepMed, Columbia, South Carolina, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Markus H.</namePart><namePart type="family">Schmidt</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Ohio Sleep Medicine Institute, Dublin, Ohio, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">John D.</namePart><namePart type="family">Hudson</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>FutureSearch Trials of Neurology, Austin, Texas, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sarah E.</namePart><namePart type="family">DeRossett</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>GlaxoSmithKline, Research Triangle Park, North Carolina, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christina E.</namePart><namePart type="family">Hill‐Zabala</namePart><namePart type="termsOfAddress">PharmD</namePart><affiliation>GlaxoSmithKline, Research Triangle Park, North Carolina, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2011-09</dateIssued><dateCaptured encoding="w3cdtf">2010-11-24</dateCaptured><dateValid encoding="w3cdtf">2011-04-04</dateValid><copyrightDate encoding="w3cdtf">2011</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">3</extent><extent unit="tables">3</extent><extent unit="references">38</extent><extent unit="words">6542</extent></physicalDescription><abstract lang="en">We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome–associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. © 2011 Movement Disorder Society</abstract><note type="content">*Funding agencies: Research funding for design and conduct of this study and for collection, management, analysis, and interpretation of the data was sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina. Preparation and review of the manuscript were sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina.</note><note type="content">*Relevant conflicts of interest/financial disclosures: Dr. John Winkelman has received consulting fees from GlaxoSmithKline. Dr. Richard Bogan has received consulting fees and research funding from GlaxoSmithKline and received research funding from XenoPort, Inc. Dr. Markus Schmidt has received consulting fees and research funding from GlaxoSmithKline and received research funding from Xenoport, Inc. Dr. John Hudson has served on the Speaker's Bureau for GlaxoSmithKline and received research funding from GlaxoSmithKline and XenoPort, Inc. Drs. DeRossett and Hill‐Zabala are employees of GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Editorial assistance was provided by Sarah Brown and Phillippa Curran of Caudex Medical, Oxford, UK (funded by GlaxoSmithKline), who collated author comments. Assistance was provided with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339:b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the acknowledgments section of the manuscript.</note><note type="content">*Full financial disclosures and author roles may be found in the online version of this article.</note><subject lang="en"><genre>Keywords</genre><topic>gabapentin enacarbil</topic><topic>polysomnography</topic><topic>restless legs syndrome</topic><topic>sleep disturbance</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2011</date><detail type="volume"><caption>vol.</caption><number>26</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>2065</start><end>2072</end><total>8</total></extent></part></relatedItem><identifier type="istex">80D3C8FB34FFAA26DF8F1C26B314839720A5D8BC</identifier><identifier type="DOI">10.1002/mds.23771</identifier><identifier type="ArticleID">MDS23771</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2011 Movement Disorder Society</accessCondition><recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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