A double blind randomized placebo control trial of levetiracetam in tourette syndrome
Identifieur interne : 001B53 ( Istex/Corpus ); précédent : 001B52; suivant : 001B54A double blind randomized placebo control trial of levetiracetam in tourette syndrome
Auteurs : Constance L. Smith-Hicks ; Dana D. Bridges ; Nina P. Paynter ; Harvey S. SingerSource :
- Movement Disorders [ 0885-3185 ] ; 2007-09-15.
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- KwdEn :
Abstract
The objective of this study was to investigate the effectiveness of levetiracetam for the treatment of tics in children with Tourette syndrome (TS). Levetiracetam, an atypical anticonvulsant, has been suggested in open‐label protocols to be an effective tic‐suppressing agent in individuals with TS. A double blind, randomized, placebo‐controlled, cross‐over trial was performed to investigate this medication in children with moderate to moderately‐severe tics. Subjects received, in a randomized sequence, 4‐weeks of levetiracetam (maximum dose 30 mg/kg/day) or placebo, with a 2‐week intervening washout period between cycles. Primary outcome measures included two separate scales from the Yale Global Tic Severity Scale; the Total Tic score and the Total overall score. Measures were assessed at baseline, prior to randomization, on Day 28 (end of Phase 1), on Day 42 (baseline for second phase) and on Day 70 (end of Phase 2). Twenty‐two subjects (21 boys and 1 girl) with TS, mean age 12.2 ± 2.3 years, range 8 to 16 years, participated. A mild reduction in tics occurred during both the levetiracetam and placebo treatment phases. There was no significant difference between treatments and no evidence of sequence or cross‐over effects. In conclusion, Levetiracetam is not more beneficial than placebo in suppressing tics in children with TS. © 2007 Movement Disorder Society
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DOI: 10.1002/mds.21615
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Smith-Hicks</name><affiliation><mods:affiliation>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</mods:affiliation></affiliation></author><author><name sortKey="Bridges, Dana D" sort="Bridges, Dana D" uniqKey="Bridges D" first="Dana D." last="Bridges">Dana D. Bridges</name><affiliation><mods:affiliation>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</mods:affiliation></affiliation></author><author><name sortKey="Paynter, Nina P" sort="Paynter, Nina P" uniqKey="Paynter N" first="Nina P." last="Paynter">Nina P. 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Levetiracetam, an atypical anticonvulsant, has been suggested in open‐label protocols to be an effective tic‐suppressing agent in individuals with TS. A double blind, randomized, placebo‐controlled, cross‐over trial was performed to investigate this medication in children with moderate to moderately‐severe tics. Subjects received, in a randomized sequence, 4‐weeks of levetiracetam (maximum dose 30 mg/kg/day) or placebo, with a 2‐week intervening washout period between cycles. Primary outcome measures included two separate scales from the Yale Global Tic Severity Scale; the Total Tic score and the Total overall score. Measures were assessed at baseline, prior to randomization, on Day 28 (end of Phase 1), on Day 42 (baseline for second phase) and on Day 70 (end of Phase 2). Twenty‐two subjects (21 boys and 1 girl) with TS, mean age 12.2 ± 2.3 years, range 8 to 16 years, participated. A mild reduction in tics occurred during both the levetiracetam and placebo treatment phases. There was no significant difference between treatments and no evidence of sequence or cross‐over effects. In conclusion, Levetiracetam is not more beneficial than placebo in suppressing tics in children with TS. © 2007 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Constance L. Smith‐Hicks MD, PhD</name><affiliations><json:string>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</json:string><json:string>Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</json:string></affiliations></json:item><json:item><name>Dana D. Bridges MS, CNFP</name><affiliations><json:string>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</json:string></affiliations></json:item><json:item><name>Nina P. Paynter MHS</name><affiliations><json:string>Department of Epidemiology Johns Hopkins University School of Public Health, Baltimore, Maryland, USA</json:string></affiliations></json:item><json:item><name>Harvey S. Singer MD</name><affiliations><json:string>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</json:string><json:string>Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Tourette syndrome</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>levetiracetam</value></json:item></subject><language><json:string>eng</json:string></language><abstract>The objective of this study was to investigate the effectiveness of levetiracetam for the treatment of tics in children with Tourette syndrome (TS). Levetiracetam, an atypical anticonvulsant, has been suggested in open‐label protocols to be an effective tic‐suppressing agent in individuals with TS. A double blind, randomized, placebo‐controlled, cross‐over trial was performed to investigate this medication in children with moderate to moderately‐severe tics. Subjects received, in a randomized sequence, 4‐weeks of levetiracetam (maximum dose 30 mg/kg/day) or placebo, with a 2‐week intervening washout period between cycles. Primary outcome measures included two separate scales from the Yale Global Tic Severity Scale; the Total Tic score and the Total overall score. Measures were assessed at baseline, prior to randomization, on Day 28 (end of Phase 1), on Day 42 (baseline for second phase) and on Day 70 (end of Phase 2). Twenty‐two subjects (21 boys and 1 girl) with TS, mean age 12.2 ± 2.3 years, range 8 to 16 years, participated. A mild reduction in tics occurred during both the levetiracetam and placebo treatment phases. There was no significant difference between treatments and no evidence of sequence or cross‐over effects. 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Levetiracetam, an atypical anticonvulsant, has been suggested in open‐label protocols to be an effective tic‐suppressing agent in individuals with TS. A double blind, randomized, placebo‐controlled, cross‐over trial was performed to investigate this medication in children with moderate to moderately‐severe tics. Subjects received, in a randomized sequence, 4‐weeks of levetiracetam (maximum dose 30 mg/kg/day) or placebo, with a 2‐week intervening washout period between cycles. Primary outcome measures included two separate scales from the Yale Global Tic Severity Scale; the Total Tic score and the Total overall score. Measures were assessed at baseline, prior to randomization, on Day 28 (end of Phase 1), on Day 42 (baseline for second phase) and on Day 70 (end of Phase 2). Twenty‐two subjects (21 boys and 1 girl) with TS, mean age 12.2 ± 2.3 years, range 8 to 16 years, participated. A mild reduction in tics occurred during both the levetiracetam and placebo treatment phases. There was no significant difference between treatments and no evidence of sequence or cross‐over effects. In conclusion, Levetiracetam is not more beneficial than placebo in suppressing tics in children with TS. © 2007 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Tourette syndrome</term></item><item><term>levetiracetam</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>Article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2007-02-02">Received</change><change when="2007-05-08">Registration</change><change when="2007-09-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/0852A20665769F49D85817386824B001869C4ACC/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. 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Levetiracetam, an atypical anticonvulsant, has been suggested in open‐label protocols to be an effective tic‐suppressing agent in individuals with TS. A double blind, randomized, placebo‐controlled, cross‐over trial was performed to investigate this medication in children with moderate to moderately‐severe tics. Subjects received, in a randomized sequence, 4‐weeks of levetiracetam (maximum dose 30 mg/kg/day) or placebo, with a 2‐week intervening washout period between cycles. Primary outcome measures included two separate scales from the Yale Global Tic Severity Scale; the Total Tic score and the Total overall score. Measures were assessed at baseline, prior to randomization, on Day 28 (end of Phase 1), on Day 42 (baseline for second phase) and on Day 70 (end of Phase 2). Twenty‐two subjects (21 boys and 1 girl) with TS, mean age 12.2 ± 2.3 years, range 8 to 16 years, participated. A mild reduction in tics occurred during both the levetiracetam and placebo treatment phases. There was no significant difference between treatments and no evidence of sequence or cross‐over effects. In conclusion, Levetiracetam is not more beneficial than placebo in suppressing tics in children with TS. © 2007 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 4-12-2015--><mods version="3.6"><titleInfo lang="en"><title>A double blind randomized placebo control trial of levetiracetam in tourette syndrome</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Placebo Control Trial of Levetiracetam in TS</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>A double blind randomized placebo control trial of levetiracetam in tourette syndrome</title></titleInfo><name type="personal"><namePart type="given">Constance L.</namePart><namePart type="family">Smith‐Hicks</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</affiliation><affiliation>Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Dana D.</namePart><namePart type="family">Bridges</namePart><namePart type="termsOfAddress">MS, CNFP</namePart><affiliation>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nina P.</namePart><namePart type="family">Paynter</namePart><namePart type="termsOfAddress">MHS</namePart><affiliation>Department of Epidemiology Johns Hopkins University School of Public Health, Baltimore, Maryland, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Harvey S.</namePart><namePart type="family">Singer</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</affiliation><affiliation>Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA</affiliation><description>Correspondence: Pediatric Neurology, Johns Hopkins School of Medicine, Harriet Lane Children's Health Building, Suite 2158, 200 N. Wolfe Street, Baltimore, MD 21287</description><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">2007-09-15</dateIssued><dateCaptured encoding="w3cdtf">2007-02-02</dateCaptured><dateValid encoding="w3cdtf">2007-05-08</dateValid><copyrightDate encoding="w3cdtf">2007</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">1</extent><extent unit="references">24</extent><extent unit="words">3543</extent></physicalDescription><abstract lang="en">The objective of this study was to investigate the effectiveness of levetiracetam for the treatment of tics in children with Tourette syndrome (TS). Levetiracetam, an atypical anticonvulsant, has been suggested in open‐label protocols to be an effective tic‐suppressing agent in individuals with TS. A double blind, randomized, placebo‐controlled, cross‐over trial was performed to investigate this medication in children with moderate to moderately‐severe tics. Subjects received, in a randomized sequence, 4‐weeks of levetiracetam (maximum dose 30 mg/kg/day) or placebo, with a 2‐week intervening washout period between cycles. Primary outcome measures included two separate scales from the Yale Global Tic Severity Scale; the Total Tic score and the Total overall score. Measures were assessed at baseline, prior to randomization, on Day 28 (end of Phase 1), on Day 42 (baseline for second phase) and on Day 70 (end of Phase 2). Twenty‐two subjects (21 boys and 1 girl) with TS, mean age 12.2 ± 2.3 years, range 8 to 16 years, participated. A mild reduction in tics occurred during both the levetiracetam and placebo treatment phases. There was no significant difference between treatments and no evidence of sequence or cross‐over effects. In conclusion, Levetiracetam is not more beneficial than placebo in suppressing tics in children with TS. © 2007 Movement Disorder Society</abstract><note type="funding">Tourette Syndrome Association</note><note type="funding">UCB</note><subject lang="en"><genre>Keywords</genre><topic>Tourette syndrome</topic><topic>levetiracetam</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></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>2007</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><detail type="issue"><caption>no.</caption><number>12</number></detail><extent unit="pages"><start>1764</start><end>1770</end><total>7</total></extent></part></relatedItem><identifier type="istex">0852A20665769F49D85817386824B001869C4ACC</identifier><identifier type="DOI">10.1002/mds.21615</identifier><identifier type="ArticleID">MDS21615</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 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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