Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial.
Identifieur interne : 001411 ( Ncbi/Merge ); précédent : 001410; suivant : 001412Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial.
Auteurs : Adam L. Boxer [États-Unis] ; Anthony E. Lang [Canada] ; Murray Grossman [États-Unis] ; David S. Knopman [États-Unis] ; Bruce L. Miller [États-Unis] ; Lon S. Schneider [États-Unis] ; Rachelle S. Doody [États-Unis] ; Andrew Lees [Royaume-Uni] ; Lawrence I. Golbe [États-Unis] ; David R. Williams [Australie] ; Jean-Cristophe Corvol [France] ; Albert Ludolph [Allemagne] ; David Burn [Royaume-Uni] ; Stefan Lorenzl [Allemagne] ; Irene Litvan [États-Unis] ; Erik D. Roberson [États-Unis] ; Günter U. Höglinger [Allemagne] ; Mary Koestler [États-Unis] ; Clifford R. Jack [États-Unis] ; Viviana Van Deerlin [États-Unis] ; Christopher Randolph [États-Unis] ; Iryna V. Lobach [États-Unis] ; Hilary W. Heuer [États-Unis] ; Illana Gozes [Israël] ; Lesley Parker [Canada] ; Steve Whitaker [États-Unis] ; Joe Hirman [États-Unis] ; Alistair J. Stewart [Canada] ; Michael Gold [États-Unis] ; Bruce H. Morimoto [États-Unis]Source :
- The Lancet. Neurology [ 1474-4465 ] ; 2014.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Oligopeptides.
- chemical , therapeutic use : Oligopeptides.
- diagnosis : Supranuclear Palsy, Progressive.
- drug therapy : Supranuclear Palsy, Progressive.
- Aged, Double-Blind Method, Female, Humans, Male, Treatment Outcome.
Abstract
In preclinical studies, davunetide promoted microtubule stability and reduced tau phosphorylation. Because progressive supranuclear palsy (PSP) is linked to tau pathology, davunetide could be a treatment for PSP. We assessed the safety and efficacy of davunetide in patients with PSP.
DOI: 10.1016/S1474-4422(14)70088-2
PubMed: 24873720
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pubmed:24873720Le document en format XML
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<author><name sortKey="Williams, David R" sort="Williams, David R" uniqKey="Williams D" first="David R" last="Williams">David R. Williams</name>
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<author><name sortKey="Lorenzl, Stefan" sort="Lorenzl, Stefan" uniqKey="Lorenzl S" first="Stefan" last="Lorenzl">Stefan Lorenzl</name>
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<author><name sortKey="Litvan, Irene" sort="Litvan, Irene" uniqKey="Litvan I" first="Irene" last="Litvan">Irene Litvan</name>
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<author><name sortKey="Roberson, Erik D" sort="Roberson, Erik D" uniqKey="Roberson E" first="Erik D" last="Roberson">Erik D. Roberson</name>
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<author><name sortKey="Hoglinger, Gunter U" sort="Hoglinger, Gunter U" uniqKey="Hoglinger G" first="Günter U" last="Höglinger">Günter U. Höglinger</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Translational Neurodegeneration, Technical University Munich, Munich, Germany.</nlm:affiliation>
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<wicri:regionArea>Department of Translational Neurodegeneration, Technical University Munich, Munich</wicri:regionArea>
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<author><name sortKey="Koestler, Mary" sort="Koestler, Mary" uniqKey="Koestler M" first="Mary" last="Koestler">Mary Koestler</name>
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<author><name sortKey="Jack, Clifford R" sort="Jack, Clifford R" uniqKey="Jack C" first="Clifford R" last="Jack">Clifford R. Jack</name>
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<author><name sortKey="Van Deerlin, Viviana" sort="Van Deerlin, Viviana" uniqKey="Van Deerlin V" first="Viviana" last="Van Deerlin">Viviana Van Deerlin</name>
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<author><name sortKey="Randolph, Christopher" sort="Randolph, Christopher" uniqKey="Randolph C" first="Christopher" last="Randolph">Christopher Randolph</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, Loyola University School of Medicine, Chicago, IL, USA.</nlm:affiliation>
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<author><name sortKey="Lobach, Iryna V" sort="Lobach, Iryna V" uniqKey="Lobach I" first="Iryna V" last="Lobach">Iryna V. Lobach</name>
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<author><name sortKey="Heuer, Hilary W" sort="Heuer, Hilary W" uniqKey="Heuer H" first="Hilary W" last="Heuer">Hilary W. Heuer</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Gozes, Illana" sort="Gozes, Illana" uniqKey="Gozes I" first="Illana" last="Gozes">Illana Gozes</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine and Sagol School of Neuroscience, Adams Super Center for Brain Studies, Tel Aviv University, Tel Aviv, Israel.</nlm:affiliation>
<country xml:lang="fr">Israël</country>
<wicri:regionArea>Department of Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine and Sagol School of Neuroscience, Adams Super Center for Brain Studies, Tel Aviv University, Tel Aviv</wicri:regionArea>
<wicri:noRegion>Tel Aviv</wicri:noRegion>
</affiliation>
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<author><name sortKey="Parker, Lesley" sort="Parker, Lesley" uniqKey="Parker L" first="Lesley" last="Parker">Lesley Parker</name>
<affiliation wicri:level="1"><nlm:affiliation>Tekmira Pharmaceuticals, Burnaby, BC, Canada.</nlm:affiliation>
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<author><name sortKey="Whitaker, Steve" sort="Whitaker, Steve" uniqKey="Whitaker S" first="Steve" last="Whitaker">Steve Whitaker</name>
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<author><name sortKey="Hirman, Joe" sort="Hirman, Joe" uniqKey="Hirman J" first="Joe" last="Hirman">Joe Hirman</name>
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<author><name sortKey="Stewart, Alistair J" sort="Stewart, Alistair J" uniqKey="Stewart A" first="Alistair J" last="Stewart">Alistair J. Stewart</name>
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<author><name sortKey="Gold, Michael" sort="Gold, Michael" uniqKey="Gold M" first="Michael" last="Gold">Michael Gold</name>
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<placeName><region type="state">Caroline du Nord</region>
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<author><name sortKey="Morimoto, Bruce H" sort="Morimoto, Bruce H" uniqKey="Morimoto B" first="Bruce H" last="Morimoto">Bruce H. Morimoto</name>
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<wicri:regionArea>Celerion, Lincoln, NE</wicri:regionArea>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial.</title>
<author><name sortKey="Boxer, Adam L" sort="Boxer, Adam L" uniqKey="Boxer A" first="Adam L" last="Boxer">Adam L. Boxer</name>
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<author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Neurology, University of Toronto, Toronto, ON, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Neurology, University of Toronto, Toronto, ON</wicri:regionArea>
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<author><name sortKey="Grossman, Murray" sort="Grossman, Murray" uniqKey="Grossman M" first="Murray" last="Grossman">Murray Grossman</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, University of Pennsylvania, Philadelphia, PA</wicri:regionArea>
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<author><name sortKey="Knopman, David S" sort="Knopman, David S" uniqKey="Knopman D" first="David S" last="Knopman">David S. Knopman</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, Mayo Clinic, Rochester, MN, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, Mayo Clinic, Rochester, MN</wicri:regionArea>
<placeName><region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Miller, Bruce L" sort="Miller, Bruce L" uniqKey="Miller B" first="Bruce L" last="Miller">Bruce L. Miller</name>
<affiliation wicri:level="2"><nlm:affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Schneider, Lon S" sort="Schneider, Lon S" uniqKey="Schneider L" first="Lon S" last="Schneider">Lon S. Schneider</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry and the Behavioural Sciences and Department of Neurology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Psychiatry and the Behavioural Sciences and Department of Neurology, Keck School of Medicine of the University of Southern California, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
<settlement type="city">Los Angeles</settlement>
</placeName>
<orgName type="university">Université de Californie du Sud</orgName>
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<author><name sortKey="Doody, Rachelle S" sort="Doody, Rachelle S" uniqKey="Doody R" first="Rachelle S" last="Doody">Rachelle S. Doody</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, Baylor College of Medicine, Houston, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, Baylor College of Medicine, Houston, TX</wicri:regionArea>
<placeName><region type="state">Texas</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Williams, David R" sort="Williams, David R" uniqKey="Williams D" first="David R" last="Williams">David R. Williams</name>
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<country xml:lang="fr">Australie</country>
<wicri:regionArea>Faculty of Medicine, Monash University, Melbourne, VIC</wicri:regionArea>
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<author><name sortKey="Corvol, Jean Cristophe" sort="Corvol, Jean Cristophe" uniqKey="Corvol J" first="Jean-Cristophe" last="Corvol">Jean-Cristophe Corvol</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Assistance Publique-Hôpitaux de Paris, INSERM, CIC1422 and UMRS1027, Sorbonne Universités, Université Pierre et Marie Curie, Paris, France; Department of Neurology, Pitié-Salpêtrière Hospital, Paris</wicri:regionArea>
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<settlement type="city">Paris</settlement>
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<author><name sortKey="Ludolph, Albert" sort="Ludolph, Albert" uniqKey="Ludolph A" first="Albert" last="Ludolph">Albert Ludolph</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, University Hospital, Ulm, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Neurology, University Hospital, Ulm</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Ulm</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Burn, David" sort="Burn, David" uniqKey="Burn D" first="David" last="Burn">David Burn</name>
<affiliation wicri:level="1"><nlm:affiliation>Institute for Ageing and Health, Newcastle University, Newcastle, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Institute for Ageing and Health, Newcastle University, Newcastle</wicri:regionArea>
<wicri:noRegion>Newcastle</wicri:noRegion>
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</author>
<author><name sortKey="Lorenzl, Stefan" sort="Lorenzl, Stefan" uniqKey="Lorenzl S" first="Stefan" last="Lorenzl">Stefan Lorenzl</name>
<affiliation wicri:level="3"><nlm:affiliation>Interdisciplinary Center for Palliative Medicine, Munich University Hospital-Klinikum Grosshadern, Munich, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Interdisciplinary Center for Palliative Medicine, Munich University Hospital-Klinikum Grosshadern, Munich</wicri:regionArea>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
<settlement type="city">Munich</settlement>
</placeName>
</affiliation>
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<author><name sortKey="Litvan, Irene" sort="Litvan, Irene" uniqKey="Litvan I" first="Irene" last="Litvan">Irene Litvan</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, University of California, San Diego, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, University of California, San Diego, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Roberson, Erik D" sort="Roberson, Erik D" uniqKey="Roberson E" first="Erik D" last="Roberson">Erik D. Roberson</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, University of Alabama, Birmingham, AL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, University of Alabama, Birmingham, AL</wicri:regionArea>
<placeName><region type="state">Alabama</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hoglinger, Gunter U" sort="Hoglinger, Gunter U" uniqKey="Hoglinger G" first="Günter U" last="Höglinger">Günter U. Höglinger</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Translational Neurodegeneration, Technical University Munich, Munich, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Translational Neurodegeneration, Technical University Munich, Munich</wicri:regionArea>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
<settlement type="city">Munich</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Koestler, Mary" sort="Koestler, Mary" uniqKey="Koestler M" first="Mary" last="Koestler">Mary Koestler</name>
<affiliation wicri:level="2"><nlm:affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jack, Clifford R" sort="Jack, Clifford R" uniqKey="Jack C" first="Clifford R" last="Jack">Clifford R. Jack</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Radiology, Mayo Clinic, Rochester, MN, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Radiology, Mayo Clinic, Rochester, MN</wicri:regionArea>
<placeName><region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Van Deerlin, Viviana" sort="Van Deerlin, Viviana" uniqKey="Van Deerlin V" first="Viviana" last="Van Deerlin">Viviana Van Deerlin</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology and Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology and Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Randolph, Christopher" sort="Randolph, Christopher" uniqKey="Randolph C" first="Christopher" last="Randolph">Christopher Randolph</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, Loyola University School of Medicine, Chicago, IL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, Loyola University School of Medicine, Chicago, IL</wicri:regionArea>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lobach, Iryna V" sort="Lobach, Iryna V" uniqKey="Lobach I" first="Iryna V" last="Lobach">Iryna V. Lobach</name>
<affiliation wicri:level="2"><nlm:affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Heuer, Hilary W" sort="Heuer, Hilary W" uniqKey="Heuer H" first="Hilary W" last="Heuer">Hilary W. Heuer</name>
<affiliation wicri:level="2"><nlm:affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gozes, Illana" sort="Gozes, Illana" uniqKey="Gozes I" first="Illana" last="Gozes">Illana Gozes</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine and Sagol School of Neuroscience, Adams Super Center for Brain Studies, Tel Aviv University, Tel Aviv, Israel.</nlm:affiliation>
<country xml:lang="fr">Israël</country>
<wicri:regionArea>Department of Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine and Sagol School of Neuroscience, Adams Super Center for Brain Studies, Tel Aviv University, Tel Aviv</wicri:regionArea>
<wicri:noRegion>Tel Aviv</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Parker, Lesley" sort="Parker, Lesley" uniqKey="Parker L" first="Lesley" last="Parker">Lesley Parker</name>
<affiliation wicri:level="1"><nlm:affiliation>Tekmira Pharmaceuticals, Burnaby, BC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Tekmira Pharmaceuticals, Burnaby, BC</wicri:regionArea>
<wicri:noRegion>BC</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Whitaker, Steve" sort="Whitaker, Steve" uniqKey="Whitaker S" first="Steve" last="Whitaker">Steve Whitaker</name>
<affiliation wicri:level="2"><nlm:affiliation>Omeros, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Omeros, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hirman, Joe" sort="Hirman, Joe" uniqKey="Hirman J" first="Joe" last="Hirman">Joe Hirman</name>
<affiliation wicri:level="2"><nlm:affiliation>Pacific Northwest Statistical Consulting, Woodinville, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Pacific Northwest Statistical Consulting, Woodinville, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stewart, Alistair J" sort="Stewart, Alistair J" uniqKey="Stewart A" first="Alistair J" last="Stewart">Alistair J. Stewart</name>
<affiliation wicri:level="1"><nlm:affiliation>Paladin Laboratories, St Laurent, QC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Paladin Laboratories, St Laurent, QC</wicri:regionArea>
<wicri:noRegion>QC</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gold, Michael" sort="Gold, Michael" uniqKey="Gold M" first="Michael" last="Gold">Michael Gold</name>
<affiliation wicri:level="2"><nlm:affiliation>UCB BioSciences, Research Triangle Park, NC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>UCB BioSciences, Research Triangle Park, NC</wicri:regionArea>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Morimoto, Bruce H" sort="Morimoto, Bruce H" uniqKey="Morimoto B" first="Bruce H" last="Morimoto">Bruce H. Morimoto</name>
<affiliation wicri:level="2"><nlm:affiliation>Celerion, Lincoln, NE, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Celerion, Lincoln, NE</wicri:regionArea>
<placeName><region type="state">Nebraska</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">The Lancet. Neurology</title>
<idno type="eISSN">1474-4465</idno>
<imprint><date when="2014" type="published">2014</date>
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<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Oligopeptides (adverse effects)</term>
<term>Oligopeptides (therapeutic use)</term>
<term>Supranuclear Palsy, Progressive (diagnosis)</term>
<term>Supranuclear Palsy, Progressive (drug therapy)</term>
<term>Treatment Outcome</term>
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<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Oligopeptides</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Supranuclear Palsy, Progressive</term>
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<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Supranuclear Palsy, Progressive</term>
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<front><div type="abstract" xml:lang="en">In preclinical studies, davunetide promoted microtubule stability and reduced tau phosphorylation. Because progressive supranuclear palsy (PSP) is linked to tau pathology, davunetide could be a treatment for PSP. We assessed the safety and efficacy of davunetide in patients with PSP.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24873720</PMID>
<DateCreated><Year>2014</Year>
<Month>06</Month>
<Day>19</Day>
</DateCreated>
<DateCompleted><Year>2014</Year>
<Month>08</Month>
<Day>11</Day>
</DateCompleted>
<DateRevised><Year>2016</Year>
<Month>12</Month>
<Day>15</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-4465</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>13</Volume>
<Issue>7</Issue>
<PubDate><Year>2014</Year>
<Month>Jul</Month>
</PubDate>
</JournalIssue>
<Title>The Lancet. Neurology</Title>
<ISOAbbreviation>Lancet Neurol</ISOAbbreviation>
</Journal>
<ArticleTitle>Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial.</ArticleTitle>
<Pagination><MedlinePgn>676-85</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/S1474-4422(14)70088-2</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S1474-4422(14)70088-2</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In preclinical studies, davunetide promoted microtubule stability and reduced tau phosphorylation. Because progressive supranuclear palsy (PSP) is linked to tau pathology, davunetide could be a treatment for PSP. We assessed the safety and efficacy of davunetide in patients with PSP.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In a double-blind, parallel group, phase 2/3 trial, participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide (30 mg twice daily, intranasally) or placebo for 52 weeks at 48 centres in Australia, Canada, France, Germany, the UK, and the USA. Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP. Primary endpoints were the change from baseline in PSP Rating Scale (PSPRS) and Schwab and England Activities of Daily Living (SEADL) scale at up to 52 weeks. All participants and study personnel were masked to treatment assignment. Analysis was by intention to treat. The trial is registered with Clinicaltrials.gov, number NCT01110720.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">313 participants were randomly assigned to davunetide (n=157) or to placebo (n=156), and 241 (77%) completed the study (118 and 156 in the davunetide and placebo groups, respectively). There were no differences in the davunetide and placebo groups in the baseline PSPRS and SEADL. The davunetide and placebo groups did not differ in the change from baseline in PSPRS (median 11·8 [95% CI 10·5 to 13·0] vs 11·8 [10·5 to 13·0], respectively, p=0·41) or SEADL (-0·20 [-0·20 to -0·17] vs -0·20 [-0·22 to -0·17], respectively, p=0·92). 54 serious adverse events were reported in each of the treatment groups, including 11 deaths in the davunetide group and ten in the placebo group. The frequency of nasal adverse events was greater in the davunetide group than in the placebo group (epistaxis 18 [12%] of 156 vs 13 [8%] of 156, rhinorrhoea 15 [10%] vs eight [5%], and nasal discomfort 15 [10%] vs one [<1%]).</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Davunetide is not an effective treatment for PSP. Clinical trials of disease-modifying treatment are feasible in patients with PSP and should be pursued with other promising tau-directed treatments.</AbstractText>
<AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Allon Therapeutics.</AbstractText>
<CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Boxer</LastName>
<ForeName>Adam L</ForeName>
<Initials>AL</Initials>
<AffiliationInfo><Affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA. Electronic address: aboxer@memory.ucsf.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lang</LastName>
<ForeName>Anthony E</ForeName>
<Initials>AE</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, University of Toronto, Toronto, ON, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Grossman</LastName>
<ForeName>Murray</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Knopman</LastName>
<ForeName>David S</ForeName>
<Initials>DS</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, Mayo Clinic, Rochester, MN, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Miller</LastName>
<ForeName>Bruce L</ForeName>
<Initials>BL</Initials>
<AffiliationInfo><Affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Schneider</LastName>
<ForeName>Lon S</ForeName>
<Initials>LS</Initials>
<AffiliationInfo><Affiliation>Department of Psychiatry and the Behavioural Sciences and Department of Neurology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Doody</LastName>
<ForeName>Rachelle S</ForeName>
<Initials>RS</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, Baylor College of Medicine, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lees</LastName>
<ForeName>Andrew</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Institute of Neurology, University College London, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Golbe</LastName>
<ForeName>Lawrence I</ForeName>
<Initials>LI</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Williams</LastName>
<ForeName>David R</ForeName>
<Initials>DR</Initials>
<AffiliationInfo><Affiliation>Faculty of Medicine, Monash University, Melbourne, VIC, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Corvol</LastName>
<ForeName>Jean-Cristophe</ForeName>
<Initials>JC</Initials>
<AffiliationInfo><Affiliation>Assistance Publique-Hôpitaux de Paris, INSERM, CIC1422 and UMRS1027, Sorbonne Universités, Université Pierre et Marie Curie, Paris, France; Department of Neurology, Pitié-Salpêtrière Hospital, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ludolph</LastName>
<ForeName>Albert</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, University Hospital, Ulm, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Burn</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Institute for Ageing and Health, Newcastle University, Newcastle, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lorenzl</LastName>
<ForeName>Stefan</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Interdisciplinary Center for Palliative Medicine, Munich University Hospital-Klinikum Grosshadern, Munich, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Litvan</LastName>
<ForeName>Irene</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, University of California, San Diego, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Roberson</LastName>
<ForeName>Erik D</ForeName>
<Initials>ED</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, University of Alabama, Birmingham, AL, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Höglinger</LastName>
<ForeName>Günter U</ForeName>
<Initials>GU</Initials>
<AffiliationInfo><Affiliation>Department of Translational Neurodegeneration, Technical University Munich, Munich, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Koestler</LastName>
<ForeName>Mary</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jack</LastName>
<ForeName>Clifford R</ForeName>
<Initials>CR</Initials>
<Suffix>Jr</Suffix>
<AffiliationInfo><Affiliation>Department of Radiology, Mayo Clinic, Rochester, MN, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Van Deerlin</LastName>
<ForeName>Viviana</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Department of Neurology and Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Randolph</LastName>
<ForeName>Christopher</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, Loyola University School of Medicine, Chicago, IL, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lobach</LastName>
<ForeName>Iryna V</ForeName>
<Initials>IV</Initials>
<AffiliationInfo><Affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Heuer</LastName>
<ForeName>Hilary W</ForeName>
<Initials>HW</Initials>
<AffiliationInfo><Affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gozes</LastName>
<ForeName>Illana</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Department of Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine and Sagol School of Neuroscience, Adams Super Center for Brain Studies, Tel Aviv University, Tel Aviv, Israel.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Parker</LastName>
<ForeName>Lesley</ForeName>
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<country name="Israël"><noRegion><name sortKey="Gozes, Illana" sort="Gozes, Illana" uniqKey="Gozes I" first="Illana" last="Gozes">Illana Gozes</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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