Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial.
Identifieur interne : 000724 ( PubMed/Curation ); précédent : 000723; suivant : 000725Davunetide 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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Lang</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Grossman, Murray" sort="Grossman, Murray" uniqKey="Grossman M" first="Murray" last="Grossman">Murray Grossman</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Pennsylvania, Philadelphia, PA</wicri:regionArea></affiliation></author><author><name sortKey="Knopman, David S" sort="Knopman, David S" uniqKey="Knopman D" first="David S" last="Knopman">David S. 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Golbe</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Williams, David R" sort="Williams, David R" uniqKey="Williams D" first="David R" last="Williams">David R. Williams</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine, Monash University, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Medicine, Monash University, Melbourne, VIC</wicri:regionArea></affiliation></author><author><name sortKey="Corvol, Jean Cristophe" sort="Corvol, Jean Cristophe" uniqKey="Corvol J" first="Jean-Cristophe" last="Corvol">Jean-Cristophe Corvol</name><affiliation wicri:level="1"><nlm: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.</nlm:affiliation><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></affiliation></author><author><name sortKey="Ludolph, Albert" sort="Ludolph, Albert" uniqKey="Ludolph A" first="Albert" last="Ludolph">Albert Ludolph</name><affiliation wicri:level="1"><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></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></affiliation></author><author><name sortKey="Lorenzl, Stefan" sort="Lorenzl, Stefan" uniqKey="Lorenzl S" first="Stefan" last="Lorenzl">Stefan Lorenzl</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Litvan, Irene" sort="Litvan, Irene" uniqKey="Litvan I" first="Irene" last="Litvan">Irene Litvan</name><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></affiliation></author><author><name sortKey="Koestler, Mary" sort="Koestler, Mary" uniqKey="Koestler M" first="Mary" last="Koestler">Mary Koestler</name><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></affiliation></author><author><name sortKey="Randolph, Christopher" sort="Randolph, Christopher" uniqKey="Randolph C" first="Christopher" last="Randolph">Christopher Randolph</name><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></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></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></affiliation></author><author><name sortKey="Whitaker, Steve" sort="Whitaker, Steve" uniqKey="Whitaker S" first="Steve" last="Whitaker">Steve Whitaker</name><affiliation wicri:level="1"><nlm:affiliation>Omeros, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Omeros, Seattle, WA</wicri:regionArea></affiliation></author><author><name sortKey="Hirman, Joe" sort="Hirman, Joe" uniqKey="Hirman J" first="Joe" last="Hirman">Joe Hirman</name><affiliation wicri:level="1"><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></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></affiliation></author><author><name sortKey="Gold, Michael" sort="Gold, Michael" uniqKey="Gold M" first="Michael" last="Gold">Michael Gold</name><affiliation wicri:level="1"><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></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="1"><nlm:affiliation>Celerion, Lincoln, NE, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celerion, Lincoln, NE</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24873720</idno><idno type="pmid">24873720</idno><idno type="doi">10.1016/S1474-4422(14)70088-2</idno><idno type="wicri:Area/PubMed/Corpus">000724</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000724</idno><idno type="wicri:Area/PubMed/Curation">000724</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000724</idno></publicationStmt><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><affiliation wicri:level="1"><nlm:affiliation>Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA. Electronic address: aboxer@memory.ucsf.edu.</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></affiliation></author><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="1"><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></affiliation></author><author><name sortKey="Grossman, Murray" sort="Grossman, Murray" uniqKey="Grossman M" first="Murray" last="Grossman">Murray Grossman</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Pennsylvania, Philadelphia, PA</wicri:regionArea></affiliation></author><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="1"><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></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="1"><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></affiliation></author><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="1"><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></affiliation></author><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="1"><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></affiliation></author><author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name><affiliation wicri:level="1"><nlm:affiliation>Institute of Neurology, University College London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Institute of Neurology, University College London</wicri:regionArea></affiliation></author><author><name sortKey="Golbe, Lawrence I" sort="Golbe, Lawrence I" uniqKey="Golbe L" first="Lawrence I" last="Golbe">Lawrence I. Golbe</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Williams, David R" sort="Williams, David R" uniqKey="Williams D" first="David R" last="Williams">David R. Williams</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine, Monash University, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Medicine, Monash University, Melbourne, VIC</wicri:regionArea></affiliation></author><author><name sortKey="Corvol, Jean Cristophe" sort="Corvol, Jean Cristophe" uniqKey="Corvol J" first="Jean-Cristophe" last="Corvol">Jean-Cristophe Corvol</name><affiliation wicri:level="1"><nlm: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.</nlm:affiliation><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></affiliation></author><author><name sortKey="Ludolph, Albert" sort="Ludolph, Albert" uniqKey="Ludolph A" first="Albert" last="Ludolph">Albert Ludolph</name><affiliation wicri:level="1"><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></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></affiliation></author><author><name sortKey="Lorenzl, Stefan" sort="Lorenzl, Stefan" uniqKey="Lorenzl S" first="Stefan" last="Lorenzl">Stefan Lorenzl</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Litvan, Irene" sort="Litvan, Irene" uniqKey="Litvan I" first="Irene" last="Litvan">Irene Litvan</name><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></affiliation></author><author><name sortKey="Koestler, Mary" sort="Koestler, Mary" uniqKey="Koestler M" first="Mary" last="Koestler">Mary Koestler</name><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></affiliation></author><author><name sortKey="Randolph, Christopher" sort="Randolph, Christopher" uniqKey="Randolph C" first="Christopher" last="Randolph">Christopher Randolph</name><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></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></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></affiliation></author><author><name sortKey="Whitaker, Steve" sort="Whitaker, Steve" uniqKey="Whitaker S" first="Steve" last="Whitaker">Steve Whitaker</name><affiliation wicri:level="1"><nlm:affiliation>Omeros, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Omeros, Seattle, WA</wicri:regionArea></affiliation></author><author><name sortKey="Hirman, Joe" sort="Hirman, Joe" uniqKey="Hirman J" first="Joe" last="Hirman">Joe Hirman</name><affiliation wicri:level="1"><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></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></affiliation></author><author><name sortKey="Gold, Michael" sort="Gold, Michael" uniqKey="Gold M" first="Michael" last="Gold">Michael Gold</name><affiliation wicri:level="1"><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></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="1"><nlm:affiliation>Celerion, Lincoln, NE, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celerion, Lincoln, NE</wicri:regionArea></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></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Double-Blind Method</term><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></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Oligopeptides</term></keywords><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></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Supranuclear Palsy, Progressive</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><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><Initials>L</Initials><AffiliationInfo><Affiliation>Tekmira Pharmaceuticals, Burnaby, BC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Whitaker</LastName><ForeName>Steve</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Omeros, Seattle, WA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hirman</LastName><ForeName>Joe</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Pacific Northwest Statistical Consulting, Woodinville, WA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stewart</LastName><ForeName>Alistair J</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>Paladin Laboratories, St Laurent, QC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gold</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>UCB BioSciences, Research Triangle Park, NC, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morimoto</LastName><ForeName>Bruce H</ForeName><Initials>BH</Initials><AffiliationInfo><Affiliation>Celerion, Lincoln, NE, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>AL-108-231 Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01110720</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>P01 AG017586</GrantID><Acronym>AG</Acronym><Agency>NIA NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>P50 AG005142</GrantID><Acronym>AG</Acronym><Agency>NIA NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>R01 AG038791</GrantID><Acronym>AG</Acronym><Agency>NIA NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate 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