BotB (botulinum Toxin type B): Evaluation of safety and tolerability in botulinum toxin type A‐Resistant cervical dystonia patients (preliminary study)
Identifieur interne : 003046 ( Istex/Corpus ); précédent : 003045; suivant : 003047BotB (botulinum Toxin type B): Evaluation of safety and tolerability in botulinum toxin type A‐Resistant cervical dystonia patients (preliminary study)
Auteurs : Truong ; Paul A. Cullis ; Christopher F. O'Brien ; Martin Koller ; Timothy P. Villegas ; Jan D. WallaceSource :
- Movement Disorders [ 0885-3185 ] ; 1997-09.
English descriptors
Abstract
Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open‐label, dose‐escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose‐limiting toxicity in this patient population. Mild‐to‐moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type‐B treatment were reported. Low‐dosing‐session (100‐‐899 units) and high‐dosing‐session (900–1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale‐Severity Scale (TWSTRS‐Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS‐Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low‐dose and high‐dose groups, respectively. Effectiveness was noted for the high‐dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.
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DOI: 10.1002/mds.870120526
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ISTEX:2D9091E7A6876B2DC33FD673B877E5D6B34A2B46Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">BotB (botulinum Toxin type B): Evaluation of safety and tolerability in botulinum toxin type A‐Resistant cervical dystonia patients (preliminary study)</title><author><name sortKey="Truong" sort="Truong" uniqKey="Truong" last="Truong">Truong</name><affiliation><mods:affiliation>Parkinson and Movement Disorders Program, Irvine, California</mods:affiliation></affiliation></author><author><name sortKey="Cullis, Paul A" sort="Cullis, Paul A" uniqKey="Cullis P" first="Paul A." last="Cullis">Paul A. Cullis</name><affiliation><mods:affiliation>Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan</mods:affiliation></affiliation></author><author><name sortKey="O Brien, Christopher F" sort="O Brien, Christopher F" uniqKey="O Brien C" first="Christopher F." last="O'Brien">Christopher F. O'Brien</name><affiliation><mods:affiliation>Colorado Neurological Institute, Denver, Colorado</mods:affiliation></affiliation></author><author><name sortKey="Koller, Martin" sort="Koller, Martin" uniqKey="Koller M" first="Martin" last="Koller">Martin Koller</name><affiliation><mods:affiliation>Athena Neurosciences, South San Francisco, California, U.S.A.</mods:affiliation></affiliation></author><author><name sortKey="Villegas, Timothy P" sort="Villegas, Timothy P" uniqKey="Villegas T" first="Timothy P." last="Villegas">Timothy P. Villegas</name><affiliation><mods:affiliation>Athena Neurosciences, South San Francisco, California, U.S.A.</mods:affiliation></affiliation></author><author><name sortKey="Wallace, Jan D" sort="Wallace, Jan D" uniqKey="Wallace J" first="Jan D." last="Wallace">Jan D. 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Cullis</name><affiliation><mods:affiliation>Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan</mods:affiliation></affiliation></author><author><name sortKey="O Brien, Christopher F" sort="O Brien, Christopher F" uniqKey="O Brien C" first="Christopher F." last="O'Brien">Christopher F. O'Brien</name><affiliation><mods:affiliation>Colorado Neurological Institute, Denver, Colorado</mods:affiliation></affiliation></author><author><name sortKey="Koller, Martin" sort="Koller, Martin" uniqKey="Koller M" first="Martin" last="Koller">Martin Koller</name><affiliation><mods:affiliation>Athena Neurosciences, South San Francisco, California, U.S.A.</mods:affiliation></affiliation></author><author><name sortKey="Villegas, Timothy P" sort="Villegas, Timothy P" uniqKey="Villegas T" first="Timothy P." last="Villegas">Timothy P. Villegas</name><affiliation><mods:affiliation>Athena Neurosciences, South San Francisco, California, U.S.A.</mods:affiliation></affiliation></author><author><name sortKey="Wallace, Jan D" sort="Wallace, Jan D" uniqKey="Wallace J" first="Jan D." last="Wallace">Jan D. Wallace</name><affiliation><mods:affiliation>Athena Neurosciences, South San Francisco, California, U.S.A.</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. 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="1997-09">1997-09</date><biblScope unit="vol">12</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="772">772</biblScope><biblScope unit="page" to="775">775</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">2D9091E7A6876B2DC33FD673B877E5D6B34A2B46</idno><idno type="DOI">10.1002/mds.870120526</idno><idno type="ArticleID">MDS870120526</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>BotB</term><term>Botulinum toxin type B</term><term>Cervical dystonia</term><term>Clinical trial</term><term>Type‐A resistance</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open‐label, dose‐escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose‐limiting toxicity in this patient population. Mild‐to‐moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type‐B treatment were reported. Low‐dosing‐session (100‐‐899 units) and high‐dosing‐session (900–1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale‐Severity Scale (TWSTRS‐Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS‐Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low‐dose and high‐dose groups, respectively. Effectiveness was noted for the high‐dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Dr. Truong</name><affiliations><json:string>Parkinson and Movement Disorders Program, Irvine, California</json:string></affiliations></json:item><json:item><name>Paul A. Cullis</name><affiliations><json:string>Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan</json:string></affiliations></json:item><json:item><name>Christopher F. O'Brien</name><affiliations><json:string>Colorado Neurological Institute, Denver, Colorado</json:string></affiliations></json:item><json:item><name>Martin Koller</name><affiliations><json:string>Athena Neurosciences, South San Francisco, California, U.S.A.</json:string></affiliations></json:item><json:item><name>Timothy P. Villegas</name><affiliations><json:string>Athena Neurosciences, South San Francisco, California, U.S.A.</json:string></affiliations></json:item><json:item><name>Jan D. Wallace</name><affiliations><json:string>Athena Neurosciences, South San Francisco, California, U.S.A.</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>BotB</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Botulinum toxin type B</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Cervical dystonia</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Type‐A resistance</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Clinical trial</value></json:item></subject><language><json:string>eng</json:string></language><abstract>Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open‐label, dose‐escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose‐limiting toxicity in this patient population. Mild‐to‐moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type‐B treatment were reported. Low‐dosing‐session (100‐‐899 units) and high‐dosing‐session (900–1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale‐Severity Scale (TWSTRS‐Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS‐Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low‐dose and high‐dose groups, respectively. 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Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="1997-09"></date><biblScope unit="vol">12</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="772">772</biblScope><biblScope unit="page" to="775">775</biblScope></imprint></monogr><idno type="istex">2D9091E7A6876B2DC33FD673B877E5D6B34A2B46</idno><idno type="DOI">10.1002/mds.870120526</idno><idno type="ArticleID">MDS870120526</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1997</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open‐label, dose‐escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose‐limiting toxicity in this patient population. Mild‐to‐moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type‐B treatment were reported. Low‐dosing‐session (100‐‐899 units) and high‐dosing‐session (900–1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale‐Severity Scale (TWSTRS‐Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS‐Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low‐dose and high‐dose groups, respectively. Effectiveness was noted for the high‐dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>BotB</term></item><item><term>Botulinum toxin type B</term></item><item><term>Cervical dystonia</term></item><item><term>Type‐A resistance</term></item><item><term>Clinical trial</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>Article category</head><item><term>Brief Report</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="1996-05-03">Received</change><change when="1997-01-07">Registration</change><change when="1997-09">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/2D9091E7A6876B2DC33FD673B877E5D6B34A2B46/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. 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We conducted a pilot, open‐label, dose‐escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose‐limiting toxicity in this patient population. Mild‐to‐moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type‐B treatment were reported. Low‐dosing‐session (100‐‐899 units) and high‐dosing‐session (900–1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale‐Severity Scale (TWSTRS‐Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS‐Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low‐dose and high‐dose groups, respectively. Effectiveness was noted for the high‐dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>BotB (botulinum Toxin type B): Evaluation of safety and tolerability in botulinum toxin type A‐Resistant cervical dystonia patients (preliminary study)</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>EVALUATION OF BotB</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>BotB (botulinum Toxin type B): Evaluation of safety and tolerability in botulinum toxin type A‐Resistant cervical dystonia patients (preliminary study)</title></titleInfo><name type="personal"><namePart type="termsOfAddress">Dr.</namePart><namePart type="family">Truong</namePart><affiliation>Parkinson and Movement Disorders Program, Irvine, California</affiliation><description>Correspondence: Parkinson's and Movement Disorders Institute, 701E 28th Street, Long Beach, CA 92806, U.S.A.</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Paul A.</namePart><namePart type="family">Cullis</namePart><affiliation>Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christopher F.</namePart><namePart type="family">O'Brien</namePart><affiliation>Colorado Neurological Institute, Denver, Colorado</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Martin</namePart><namePart type="family">Koller</namePart><affiliation>Athena Neurosciences, South San Francisco, California, U.S.A.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Timothy P.</namePart><namePart type="family">Villegas</namePart><affiliation>Athena Neurosciences, South San Francisco, California, U.S.A.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jan D.</namePart><namePart type="family">Wallace</namePart><affiliation>Athena Neurosciences, South San Francisco, California, U.S.A.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">1997-09</dateIssued><dateCaptured encoding="w3cdtf">1996-05-03</dateCaptured><dateValid encoding="w3cdtf">1997-01-07</dateValid><copyrightDate encoding="w3cdtf">1997</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="tables">2</extent><extent unit="references">7</extent></physicalDescription><abstract lang="en">Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open‐label, dose‐escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose‐limiting toxicity in this patient population. Mild‐to‐moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type‐B treatment were reported. Low‐dosing‐session (100‐‐899 units) and high‐dosing‐session (900–1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale‐Severity Scale (TWSTRS‐Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS‐Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low‐dose and high‐dose groups, respectively. Effectiveness was noted for the high‐dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.</abstract><subject lang="en"><genre>Keywords</genre><topic>BotB</topic><topic>Botulinum toxin type B</topic><topic>Cervical dystonia</topic><topic>Type‐A resistance</topic><topic>Clinical trial</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><subject><genre>article category</genre><topic>Brief Report</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>1997</date><detail type="volume"><caption>vol.</caption><number>12</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>772</start><end>775</end><total>4</total></extent></part></relatedItem><identifier type="istex">2D9091E7A6876B2DC33FD673B877E5D6B34A2B46</identifier><identifier type="DOI">10.1002/mds.870120526</identifier><identifier type="ArticleID">MDS870120526</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 1997 Movement Disorder Society</accessCondition><recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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