Pilot efficacy and tolerability: a randomized, placebo-controlled trial of levetiracetam for essential tremor.
Identifieur interne : 003294 ( PubMed/Curation ); précédent : 003293; suivant : 003295Pilot efficacy and tolerability: a randomized, placebo-controlled trial of levetiracetam for essential tremor.
Auteurs : Adrian Handforth [États-Unis] ; Fredricka C. MartinSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2004.
English descriptors
- KwdEn :
- Aged, Anticonvulsants (adverse effects), Anticonvulsants (therapeutic use), Cross-Over Studies, Double-Blind Method, Essential Tremor (drug therapy), Female, Humans, Male, Pilot Projects, Piracetam (adverse effects), Piracetam (analogs & derivatives), Piracetam (therapeutic use), Severity of Illness Index.
- MESH :
- chemical , adverse effects : Anticonvulsants, Piracetam.
- chemical , analogs & derivatives : Piracetam.
- chemical , therapeutic use : Anticonvulsants, Piracetam.
- drug therapy : Essential Tremor.
- Aged, Cross-Over Studies, Double-Blind Method, Female, Humans, Male, Pilot Projects, Severity of Illness Index.
Abstract
The purpose of this pilot single-site study was to assess efficacy and safety of levetiracetam for essential tremor, using a placebo-controlled, double-blind, randomized crossover design with an interim analysis planned after completion of the first 10 to 15 subjects. The study was designed to detect a mean 30% reduction in composite tremor score, comparable to that of primidone or propranolol, which can be demonstrated with 30 or fewer subjects. Each treatment arm included baseline tremor assessments, a 4-week medication titration, 2 weeks of stable dose, and treatment tremor assessments. Levetiracetam was titrated to 3,000 mg/day or to a lower maximal tolerated dose. The median age was 72 years, with 28 years median tremor duration. There was no statistically significant difference in response between placebo and levetiracetam on any tremor rating scale or accelerometry measure. The 95% confidence interval for the true mean difference between placebo and levetiracetam treatments was +18.5 to -22.5%, which excludes the minimum 30% drop required to consider levetiracetam clinically effective to a degree comparable to primidone or propranolol. Whether levetiracetam has lesser-degree antitremor efficacy was not addressed in this pilot study.
DOI: 10.1002/mds.20147
PubMed: 15390011
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Martin</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2004">2004</date><idno type="RBID">pubmed:15390011</idno><idno type="pmid">15390011</idno><idno type="doi">10.1002/mds.20147</idno><idno type="wicri:Area/PubMed/Corpus">003294</idno><idno type="wicri:Area/PubMed/Curation">003294</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Pilot efficacy and tolerability: a randomized, placebo-controlled trial of levetiracetam for essential tremor.</title><author><name sortKey="Handforth, Adrian" sort="Handforth, Adrian" uniqKey="Handforth A" first="Adrian" last="Handforth">Adrian Handforth</name><affiliation wicri:level="1"><nlm:affiliation>Neurology Services, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California 90073, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Neurology Services, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California 90073</wicri:regionArea></affiliation></author><author><name sortKey="Martin, Fredricka C" sort="Martin, Fredricka C" uniqKey="Martin F" first="Fredricka C" last="Martin">Fredricka C. Martin</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="2004" type="published">2004</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Anticonvulsants (adverse effects)</term><term>Anticonvulsants (therapeutic use)</term><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Essential Tremor (drug therapy)</term><term>Female</term><term>Humans</term><term>Male</term><term>Pilot Projects</term><term>Piracetam (adverse effects)</term><term>Piracetam (analogs & derivatives)</term><term>Piracetam (therapeutic use)</term><term>Severity of Illness Index</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anticonvulsants</term><term>Piracetam</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>Essential Tremor</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Pilot Projects</term><term>Severity of Illness Index</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The purpose of this pilot single-site study was to assess efficacy and safety of levetiracetam for essential tremor, using a placebo-controlled, double-blind, randomized crossover design with an interim analysis planned after completion of the first 10 to 15 subjects. The study was designed to detect a mean 30% reduction in composite tremor score, comparable to that of primidone or propranolol, which can be demonstrated with 30 or fewer subjects. Each treatment arm included baseline tremor assessments, a 4-week medication titration, 2 weeks of stable dose, and treatment tremor assessments. Levetiracetam was titrated to 3,000 mg/day or to a lower maximal tolerated dose. The median age was 72 years, with 28 years median tremor duration. There was no statistically significant difference in response between placebo and levetiracetam on any tremor rating scale or accelerometry measure. The 95% confidence interval for the true mean difference between placebo and levetiracetam treatments was +18.5 to -22.5%, which excludes the minimum 30% drop required to consider levetiracetam clinically effective to a degree comparable to primidone or propranolol. Whether levetiracetam has lesser-degree antitremor efficacy was not addressed in this pilot study.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">15390011</PMID><DateCreated><Year>2004</Year><Month>10</Month><Day>06</Day></DateCreated><DateCompleted><Year>2005</Year><Month>02</Month><Day>14</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>19</Volume><Issue>10</Issue><PubDate><Year>2004</Year><Month>Oct</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Pilot efficacy and tolerability: a randomized, placebo-controlled trial of levetiracetam for essential tremor.</ArticleTitle><Pagination><MedlinePgn>1215-21</MedlinePgn></Pagination><Abstract><AbstractText>The purpose of this pilot single-site study was to assess efficacy and safety of levetiracetam for essential tremor, using a placebo-controlled, double-blind, randomized crossover design with an interim analysis planned after completion of the first 10 to 15 subjects. The study was designed to detect a mean 30% reduction in composite tremor score, comparable to that of primidone or propranolol, which can be demonstrated with 30 or fewer subjects. Each treatment arm included baseline tremor assessments, a 4-week medication titration, 2 weeks of stable dose, and treatment tremor assessments. Levetiracetam was titrated to 3,000 mg/day or to a lower maximal tolerated dose. The median age was 72 years, with 28 years median tremor duration. There was no statistically significant difference in response between placebo and levetiracetam on any tremor rating scale or accelerometry measure. The 95% confidence interval for the true mean difference between placebo and levetiracetam treatments was +18.5 to -22.5%, which excludes the minimum 30% drop required to consider levetiracetam clinically effective to a degree comparable to primidone or propranolol. Whether levetiracetam has lesser-degree antitremor efficacy was not addressed in this pilot study.</AbstractText><CopyrightInformation>(c) 2004 Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Handforth</LastName><ForeName>Adrian</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Neurology Services, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California 90073, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Martin</LastName><ForeName>Fredricka C</ForeName><Initials>FC</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><PublicationType UI="D013486">Research Support, U.S. Gov't, Non-P.H.S.</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><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Mov Disord. 2005 May;20(5):640</RefSource><PMID Version="1">15756652</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000927">Anticonvulsants</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018592">Cross-Over Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D020329">Essential Tremor</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></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="D010865">Pilot Projects</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010889">Piracetam</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000009">adverse effects</QualifierName><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></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2004</Year><Month>9</Month><Day>25</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2005</Year><Month>2</Month><Day>16</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2004</Year><Month>9</Month><Day>25</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">15390011</ArticleId><ArticleId IdType="doi">10.1002/mds.20147</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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