Botulinum toxin type B (Myobloc) in subjects with hemifacial spasm: results from an open-label, dose-escalation safety study.
Identifieur interne : 002608 ( PubMed/Corpus ); précédent : 002607; suivant : 002609Botulinum toxin type B (Myobloc) in subjects with hemifacial spasm: results from an open-label, dose-escalation safety study.
Auteurs : Richard M. Trosch ; 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
Links to Exploration step
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><nlm:affiliation>The Parkinson's Disease and Movement Disorders Center, 26400 W, Southfield, Michigan, USA.</nlm:affiliation>
</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>
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<idno type="doi">10.1002/mds.21435</idno>
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<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><nlm:affiliation>The Parkinson's Disease and Movement Disorders Center, 26400 W, Southfield, Michigan, USA.</nlm:affiliation>
</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>
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<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>
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<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>
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<Language>eng</Language>
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<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Mov Disord</MedlineTA>
<NlmUniqueID>8610688</NlmUniqueID>
<ISSNLinking>0885-3185</ISSNLinking>
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<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>
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<MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName>
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<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>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D001905">Botulinum Toxins</DescriptorName>
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<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>
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<Month>6</Month>
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