A double blind randomized placebo control trial of levetiracetam in tourette syndrome
Identifieur interne : 003061 ( Main/Exploration ); précédent : 003060; suivant : 003062A double blind randomized placebo control trial of levetiracetam in tourette syndrome
Auteurs : Constance L. Smith-Hicks [États-Unis] ; Dana D. Bridges [États-Unis] ; Nina P. Paynter [États-Unis] ; Harvey S. Singer [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2007-09-15.
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), Tourette syndrome, levetiracetam.
- 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. © 2007 Movement Disorder Society
Url:
DOI: 10.1002/mds.21615
Affiliations:
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Smith-Hicks</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Bridges, Dana D" sort="Bridges, Dana D" uniqKey="Bridges D" first="Dana D." last="Bridges">Dana D. 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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="2007-09-15">2007-09-15</date><biblScope unit="vol">22</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1764">1764</biblScope><biblScope unit="page" to="1770">1770</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">0852A20665769F49D85817386824B001869C4ACC</idno><idno type="DOI">10.1002/mds.21615</idno><idno type="ArticleID">MDS21615</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></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><term>Tourette syndrome</term><term>levetiracetam</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><langUsage><language ident="en">en</language></langUsage></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. © 2007 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Maryland</li></region></list><tree><country name="États-Unis"><region name="Maryland"><name sortKey="Smith Icks, Constance L" sort="Smith Icks, Constance L" uniqKey="Smith Icks C" first="Constance L." last="Smith-Hicks">Constance L. Smith-Hicks</name></region><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><name sortKey="Singer, Harvey S" sort="Singer, Harvey S" uniqKey="Singer H" first="Harvey S." last="Singer">Harvey S. Singer</name><name sortKey="Smith Icks, Constance L" sort="Smith Icks, Constance L" uniqKey="Smith Icks C" first="Constance L." last="Smith-Hicks">Constance L. Smith-Hicks</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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