A double blind randomized placebo control trial of levetiracetam in Tourette syndrome.
Identifieur interne : 002A17 ( PubMed/Checkpoint ); précédent : 002A16; suivant : 002A18A double blind randomized placebo control trial of levetiracetam in Tourette syndrome.
Auteurs : Constance L. Smith-Hicks [États-Unis] ; Dana D. Bridges ; Nina P. Paynter ; Harvey S. SingerSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2007.
English descriptors
- KwdEn :
- Adolescent, Anticonvulsants (therapeutic use), Child, Confidence Intervals, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Piracetam (analogs & derivatives), Piracetam (therapeutic use), Severity of Illness Index, Time Factors, Tourette Syndrome (drug therapy).
- MESH :
- chemical , analogs & derivatives : Piracetam.
- chemical , therapeutic use : Anticonvulsants, Piracetam.
- drug therapy : Tourette Syndrome.
- Adolescent, Child, Confidence Intervals, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Severity of Illness Index, Time Factors.
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.
DOI: 10.1002/mds.21615
PubMed: 17566124
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A double blind randomized placebo control trial of levetiracetam in Tourette syndrome.</title><author><name sortKey="Smith Hicks, Constance L" sort="Smith Hicks, Constance L" uniqKey="Smith Hicks C" first="Constance L" last="Smith-Hicks">Constance L. Smith-Hicks</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287</wicri:regionArea><wicri:noRegion>Maryland 21287</wicri:noRegion></affiliation></author><author><name sortKey="Bridges, Dana D" sort="Bridges, Dana D" uniqKey="Bridges D" first="Dana D" last="Bridges">Dana D. Bridges</name></author><author><name sortKey="Paynter, Nina P" sort="Paynter, Nina P" uniqKey="Paynter N" first="Nina P" last="Paynter">Nina P. Paynter</name></author><author><name sortKey="Singer, Harvey S" sort="Singer, Harvey S" uniqKey="Singer H" first="Harvey S" last="Singer">Harvey S. Singer</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2007">2007</date><idno type="doi">10.1002/mds.21615</idno><idno type="RBID">pubmed:17566124</idno><idno type="pmid">17566124</idno><idno type="wicri:Area/PubMed/Corpus">002634</idno><idno type="wicri:Area/PubMed/Curation">002634</idno><idno type="wicri:Area/PubMed/Checkpoint">002A17</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A double blind randomized placebo control trial of levetiracetam in Tourette syndrome.</title><author><name sortKey="Smith Hicks, Constance L" sort="Smith Hicks, Constance L" uniqKey="Smith Hicks C" first="Constance L" last="Smith-Hicks">Constance L. Smith-Hicks</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287</wicri:regionArea><wicri:noRegion>Maryland 21287</wicri:noRegion></affiliation></author><author><name sortKey="Bridges, Dana D" sort="Bridges, Dana D" uniqKey="Bridges D" first="Dana D" last="Bridges">Dana D. Bridges</name></author><author><name sortKey="Paynter, Nina P" sort="Paynter, Nina P" uniqKey="Paynter N" first="Nina P" last="Paynter">Nina P. Paynter</name></author><author><name sortKey="Singer, Harvey S" sort="Singer, Harvey S" uniqKey="Singer H" first="Harvey S" last="Singer">Harvey S. Singer</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2007" type="published">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Anticonvulsants (therapeutic use)</term><term>Child</term><term>Confidence Intervals</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Piracetam (analogs & derivatives)</term><term>Piracetam (therapeutic use)</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Tourette Syndrome (drug therapy)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Piracetam</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anticonvulsants</term><term>Piracetam</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Tourette Syndrome</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Child</term><term>Confidence Intervals</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml: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.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">17566124</PMID><DateCreated><Year>2007</Year><Month>10</Month><Day>01</Day></DateCreated><DateCompleted><Year>2008</Year><Month>01</Month><Day>09</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>22</Volume><Issue>12</Issue><PubDate><Year>2007</Year><Month>Sep</Month><Day>15</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>A double blind randomized placebo control trial of levetiracetam in Tourette syndrome.</ArticleTitle><Pagination><MedlinePgn>1764-70</MedlinePgn></Pagination><Abstract><AbstractText>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.</AbstractText><CopyrightInformation>(c) 2007 Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Smith-Hicks</LastName><ForeName>Constance L</ForeName><Initials>CL</Initials><AffiliationInfo><Affiliation>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bridges</LastName><ForeName>Dana D</ForeName><Initials>DD</Initials></Author><Author ValidYN="Y"><LastName>Paynter</LastName><ForeName>Nina P</ForeName><Initials>NP</Initials></Author><Author ValidYN="Y"><LastName>Singer</LastName><ForeName>Harvey S</ForeName><Initials>HS</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000927">Anticonvulsants</NameOfSubstance></Chemical><Chemical><RegistryNumber>230447L0GL</RegistryNumber><NameOfSubstance UI="C026098">etiracetam</NameOfSubstance></Chemical><Chemical><RegistryNumber>ZH516LNZ10</RegistryNumber><NameOfSubstance UI="D010889">Piracetam</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000293">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000927">Anticonvulsants</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D002648">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016001">Confidence Intervals</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004334">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010889">Piracetam</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000031">analogs & derivatives</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012720">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005879">Tourette Syndrome</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2007</Year><Month>6</Month><Day>15</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2008</Year><Month>1</Month><Day>10</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2007</Year><Month>6</Month><Day>15</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.21615</ArticleId><ArticleId IdType="pubmed">17566124</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country></list><tree><noCountry><name sortKey="Bridges, Dana D" sort="Bridges, Dana D" uniqKey="Bridges D" first="Dana D" last="Bridges">Dana D. Bridges</name><name sortKey="Paynter, Nina P" sort="Paynter, Nina P" uniqKey="Paynter N" first="Nina P" last="Paynter">Nina P. Paynter</name><name sortKey="Singer, Harvey S" sort="Singer, Harvey S" uniqKey="Singer H" first="Harvey S" last="Singer">Harvey S. Singer</name></noCountry><country name="États-Unis"><noRegion><name sortKey="Smith Hicks, Constance L" sort="Smith Hicks, Constance L" uniqKey="Smith Hicks C" first="Constance L" last="Smith-Hicks">Constance L. Smith-Hicks</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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