A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin®) in cervical dystonia
Identifieur interne : 000414 ( Ncbi/Checkpoint ); précédent : 000413; suivant : 000415A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin®) in cervical dystonia
Auteurs : Virgilio Evidente [États-Unis] ; Hubert Fernandez [États-Unis] ; Mark Ledoux [États-Unis] ; Allison Brashear [États-Unis] ; Susanne Grafe [Allemagne] ; Angelika Hanschmann [Allemagne] ; Cynthia Comella [États-Unis]Source :
- Journal of Neural Transmission [ 0300-9564 ] ; 2013.
Abstract
IncobotulinumtoxinA (Xeomin®, NT 201), a preparation without accessory (complexing) proteins, has shown comparable efficacy and safety to onabotulinumtoxinA in treating cervical dystonia (CD). This study evaluated the efficacy and safety of repeated incobotulinumtoxinA injections in subjects with CD. Following a ≤20-week placebo-controlled, randomized, double-blind, single-dose main period, subjects could enter a ≤68-week prospective, randomized, double-blind, repeated-dose, flexible-interval (minimum 6 weeks) extension period with 240 U or 120 U of incobotulinumtoxinA (≤5 injections). Outcome measures included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and adverse events (AEs). Of 219 subjects completing the main period, 214 were randomized in the extension period to receive incobotulinumtoxinA 240 U (
Url:
DOI: 10.1007/s00702-013-1048-3
PubMed: 23779062
PubMed Central: 3834167
Affiliations:
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin<sup>®</sup>
) in cervical dystonia</title>
<author><name sortKey="Evidente, Virgilio Gerald H" sort="Evidente, Virgilio Gerald H" uniqKey="Evidente V" first="Virgilio" last="Evidente">Virgilio Evidente</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Arizona</region>
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<wicri:cityArea>Movement Disorders Center of Arizona, 9590 E. Ironwood Square Drive, #225, Scottsdale</wicri:cityArea>
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<author><name sortKey="Fernandez, Hubert H" sort="Fernandez, Hubert H" uniqKey="Fernandez H" first="Hubert" last="Fernandez">Hubert Fernandez</name>
<affiliation wicri:level="2"><nlm:aff id="Aff2">Cleveland Clinic, Cleveland, OH USA</nlm:aff>
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<placeName><region type="state">Ohio</region>
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<wicri:cityArea>Cleveland Clinic, Cleveland</wicri:cityArea>
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<author><name sortKey="Ledoux, Mark S" sort="Ledoux, Mark S" uniqKey="Ledoux M" first="Mark" last="Ledoux">Mark Ledoux</name>
<affiliation wicri:level="2"><nlm:aff id="Aff3">University of Tennessee Health Science Center, Memphis, TN USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Tennessee</region>
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<wicri:cityArea>University of Tennessee Health Science Center, Memphis</wicri:cityArea>
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<author><name sortKey="Brashear, Allison" sort="Brashear, Allison" uniqKey="Brashear A" first="Allison" last="Brashear">Allison Brashear</name>
<affiliation wicri:level="2"><nlm:aff id="Aff4">Wake Forest School of Medicine, Winston-Salem, NC USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
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<wicri:cityArea>Wake Forest School of Medicine, Winston-Salem</wicri:cityArea>
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<author><name sortKey="Grafe, Susanne" sort="Grafe, Susanne" uniqKey="Grafe S" first="Susanne" last="Grafe">Susanne Grafe</name>
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<wicri:noRegion>Frankfurt</wicri:noRegion>
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<author><name sortKey="Hanschmann, Angelika" sort="Hanschmann, Angelika" uniqKey="Hanschmann A" first="Angelika" last="Hanschmann">Angelika Hanschmann</name>
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<wicri:noRegion>Frankfurt</wicri:noRegion>
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<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia" last="Comella">Cynthia Comella</name>
<affiliation wicri:level="2"><nlm:aff id="Aff6">Rush University Medical Center, Chicago, IL USA</nlm:aff>
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<series><title level="j">Journal of Neural Transmission</title>
<idno type="ISSN">0300-9564</idno>
<idno type="e-ISSN">1435-1463</idno>
<imprint><date when="2013">2013</date>
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<front><div type="abstract" xml:lang="en"><p>IncobotulinumtoxinA (Xeomin<sup>®</sup>
, NT 201), a preparation without accessory (complexing) proteins, has shown comparable efficacy and safety to onabotulinumtoxinA in treating cervical dystonia (CD). This study evaluated the efficacy and safety of repeated incobotulinumtoxinA injections in subjects with CD. Following a ≤20-week placebo-controlled, randomized, double-blind, single-dose main period, subjects could enter a ≤68-week prospective, randomized, double-blind, repeated-dose, flexible-interval (minimum 6 weeks) extension period with 240 U or 120 U of incobotulinumtoxinA (≤5 injections). Outcome measures included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and adverse events (AEs). Of 219 subjects completing the main period, 214 were randomized in the extension period to receive incobotulinumtoxinA 240 U (<italic>n</italic>
= 111) or 120 U (<italic>n</italic>
= 103); 169 subjects completed the extension period, with 90 receiving five injection sessions. Both doses of incobotulinumtoxinA provided statistically significant and clinically relevant improvements in mean TWSTRS-Total, -Severity, -Disability, and -Pain scores, from each injection session to respective 4-week follow-up visits. The most frequently reported AE was dysphagia (240 U: 23.4 %; 120 U: 12.6 %), which did not result in any study withdrawals. There was no impact of injection interval on the incidence of AEs (post hoc analysis). A major limitation of this study was the fixed dose design requested by regulatory authorities, which does not reflect clinical practice. However, repeated incobotulinumtoxinA injections (240 or 120 U; flexible intervals) provided sustained efficacy and were well tolerated, with no unexpected safety risks following repeated injections. The incidence of AEs was similar in subjects requiring repeated injections at shorter intervals (≤12 weeks) compared with those treated using longer intervals (>12 weeks).</p>
</div>
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<author><name sortKey="Muller, J" uniqKey="Muller J">J Müller</name>
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<author><name sortKey="Dressnandt, J" uniqKey="Dressnandt J">J Dressnandt</name>
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<author><name sortKey="Heinen, F" uniqKey="Heinen F">F Heinen</name>
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<author><name sortKey="Naumann, M" uniqKey="Naumann M">M Naumann</name>
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<author><name sortKey="Topka, H" uniqKey="Topka H">H Topka</name>
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<li>Caroline du Nord</li>
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<li>Tennessee</li>
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<tree><country name="États-Unis"><region name="Arizona"><name sortKey="Evidente, Virgilio Gerald H" sort="Evidente, Virgilio Gerald H" uniqKey="Evidente V" first="Virgilio" last="Evidente">Virgilio Evidente</name>
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<name sortKey="Brashear, Allison" sort="Brashear, Allison" uniqKey="Brashear A" first="Allison" last="Brashear">Allison Brashear</name>
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<name sortKey="Fernandez, Hubert H" sort="Fernandez, Hubert H" uniqKey="Fernandez H" first="Hubert" last="Fernandez">Hubert Fernandez</name>
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<name sortKey="Hanschmann, Angelika" sort="Hanschmann, Angelika" uniqKey="Hanschmann A" first="Angelika" last="Hanschmann">Angelika Hanschmann</name>
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