Botulinum toxin type B (Myobloc) in subjects with hemifacial spasm: results from an open-label, dose-escalation safety study.
Identifieur interne : 001D51 ( Ncbi/Merge ); précédent : 001D50; suivant : 001D52Botulinum toxin type B (Myobloc) in subjects with hemifacial spasm: results from an open-label, dose-escalation safety study.
Auteurs : Richard M. Trosch [États-Unis] ; Charles H. Adler ; Eric J. PappertSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2007.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Anti-Dyskinesia Agents, Botulinum Toxins.
- drug therapy : Hemifacial Spasm.
- Adult, Aged, Dose-Response Relationship, Drug, Drug Evaluation, Female, Humans, Male, Middle Aged, Pain Measurement, Time Factors, Treatment Outcome.
Abstract
Evaluate the safety of botulinum toxin type B (BoNT-B) in subjects with hemifacial spasm (HFS).
DOI: 10.1002/mds.21435
PubMed: 17588242
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pubmed:17588242Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Botulinum toxin type B (Myobloc) in subjects with hemifacial spasm: results from an open-label, dose-escalation safety study.</title><author><name sortKey="Trosch, Richard M" sort="Trosch, Richard M" uniqKey="Trosch R" first="Richard M" last="Trosch">Richard M. Trosch</name><affiliation wicri:level="2"><nlm:affiliation>The Parkinson's Disease and Movement Disorders Center, 26400 W, Southfield, Michigan, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The Parkinson's Disease and Movement Disorders Center, 26400 W, Southfield, Michigan</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Adler, Charles H" sort="Adler, Charles H" uniqKey="Adler C" first="Charles H" last="Adler">Charles H. Adler</name></author><author><name sortKey="Pappert, Eric J" sort="Pappert, Eric J" uniqKey="Pappert E" first="Eric J" last="Pappert">Eric J. Pappert</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2007">2007</date><idno type="doi">10.1002/mds.21435</idno><idno type="RBID">pubmed:17588242</idno><idno type="pmid">17588242</idno><idno type="wicri:Area/PubMed/Corpus">002608</idno><idno type="wicri:Area/PubMed/Curation">002608</idno><idno type="wicri:Area/PubMed/Checkpoint">002938</idno><idno type="wicri:Area/Ncbi/Merge">001D51</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Botulinum toxin type B (Myobloc) in subjects with hemifacial spasm: results from an open-label, dose-escalation safety study.</title><author><name sortKey="Trosch, Richard M" sort="Trosch, Richard M" uniqKey="Trosch R" first="Richard M" last="Trosch">Richard M. Trosch</name><affiliation wicri:level="2"><nlm:affiliation>The Parkinson's Disease and Movement Disorders Center, 26400 W, Southfield, Michigan, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The Parkinson's Disease and Movement Disorders Center, 26400 W, Southfield, Michigan</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Adler, Charles H" sort="Adler, Charles H" uniqKey="Adler C" first="Charles H" last="Adler">Charles H. Adler</name></author><author><name sortKey="Pappert, Eric J" sort="Pappert, Eric J" uniqKey="Pappert E" first="Eric J" last="Pappert">Eric J. Pappert</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2007" type="published">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Anti-Dyskinesia Agents (therapeutic use)</term><term>Botulinum Toxins (therapeutic use)</term><term>Dose-Response Relationship, Drug</term><term>Drug Evaluation</term><term>Female</term><term>Hemifacial Spasm (drug therapy)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pain Measurement</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Dyskinesia Agents</term><term>Botulinum Toxins</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hemifacial Spasm</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Drug Evaluation</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pain Measurement</term><term>Time Factors</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Evaluate the safety of botulinum toxin type B (BoNT-B) in subjects with hemifacial spasm (HFS).</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">17588242</PMID><DateCreated><Year>2007</Year><Month>07</Month><Day>30</Day></DateCreated><DateCompleted><Year>2008</Year><Month>04</Month><Day>16</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>25</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>22</Volume><Issue>9</Issue><PubDate><Year>2007</Year><Month>Jul</Month><Day>15</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Botulinum toxin type B (Myobloc) in subjects with hemifacial spasm: results from an open-label, dose-escalation safety study.</ArticleTitle><Pagination><MedlinePgn>1258-64</MedlinePgn></Pagination><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Evaluate the safety of botulinum toxin type B (BoNT-B) in subjects with hemifacial spasm (HFS).</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This open-label, sequential dose-escalation study evaluated BoNT-B in subjects with HFS. Eligible subjects were enrolled and received a single injection of one of four sequential BoNT-B doses (100, 200, 400, or 800 U). Following injection, subjects were evaluated in person at Weeks 2 and 8 and by phone at Weeks 1, 4, and 10 and every 2 weeks thereafter until benefit was lost. Safety was assessed by adverse events (AEs), vital signs and clinical laboratory evaluation. The severity of HFS was assessed using a patient social impairment visual analog scale (VAS), subject severity of contraction VAS, the HFS physician assessment, and subject HFS frequency and severity assessment.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Nineteen predominately Caucasian (92%) and female (67%) subjects (aged 36-80 years) with HFS participated in this study. Subjects remained in the study an average of 88 days (range of 41-332 days) after receiving a single dose of BoNT-B. No deaths, serious AEs or AEs leading to trial discontinuation occurred during the study period. Two subjects in the 400 U dose group requested early withdrawal, whereas all other subjects completed the study. A reduction in HFS severity was observed in subjects treated with doses of 200 U or more. Improvements in subject HFS assessments tended to return to baseline values by 8 weeks following injection.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">BoNT-B was well-tolerated and reduced HFS severity in subjects who received injections of 200 to 800 U. Additional investigation is necessary to confirm the findings from this open-label study.</AbstractText><CopyrightInformation>2007 Movement Disorder Society</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Trosch</LastName><ForeName>Richard M</ForeName><Initials>RM</Initials><AffiliationInfo><Affiliation>The Parkinson's Disease and Movement Disorders Center, 26400 W, Southfield, Michigan, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Adler</LastName><ForeName>Charles H</ForeName><Initials>CH</Initials></Author><Author ValidYN="Y"><LastName>Pappert</LastName><ForeName>Eric J</ForeName><Initials>EJ</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D018848">Controlled Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</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="D018726">Anti-Dyskinesia Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0Y70779M1F</RegistryNumber><NameOfSubstance UI="C096323">rimabotulinumtoxinB</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.24.69</RegistryNumber><NameOfSubstance UI="D001905">Botulinum Toxins</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018726">Anti-Dyskinesia Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D001905">Botulinum Toxins</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D004341">Drug Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019569">Hemifacial Spasm</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010147">Pain Measurement</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2007</Year><Month>6</Month><Day>26</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2008</Year><Month>4</Month><Day>17</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2007</Year><Month>6</Month><Day>26</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.21435</ArticleId><ArticleId IdType="pubmed">17588242</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Michigan</li></region></list><tree><noCountry><name sortKey="Adler, Charles H" sort="Adler, Charles H" uniqKey="Adler C" first="Charles H" last="Adler">Charles H. Adler</name><name sortKey="Pappert, Eric J" sort="Pappert, Eric J" uniqKey="Pappert E" first="Eric J" last="Pappert">Eric J. Pappert</name></noCountry><country name="États-Unis"><region name="Michigan"><name sortKey="Trosch, Richard M" sort="Trosch, Richard M" uniqKey="Trosch R" first="Richard M" last="Trosch">Richard M. Trosch</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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