Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.
Identifieur interne : 004240 ( Ncbi/Merge ); précédent : 004239; suivant : 004241Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.
Auteurs : Vincent Meininger [France] ; Angela Genge [Canada] ; Leonard H. Van Den Berg [Pays-Bas] ; Wim Robberecht [Belgique] ; Albert Ludolph [Allemagne] ; Adriano Chio [Italie] ; Seung H. Kim [Corée du Sud] ; P Nigel Leigh [Royaume-Uni] ; Matthew C. Kiernan [Australie] ; Jeremy M. Shefner [États-Unis] ; Claude Desnuelle [France] ; Karen E. Morrison [Royaume-Uni] ; Susanne Petri [Allemagne] ; Diane Boswell [Royaume-Uni] ; Jane Temple [Royaume-Uni] ; Rajat Mohindra [Royaume-Uni] ; Matt Davies [Royaume-Uni] ; Jonathan Bullman [Royaume-Uni] ; Paul Rees [Royaume-Uni] ; Arseniy Lavrov [Royaume-Uni]Source :
- The Lancet. Neurology [ 1474-4465 ] ; 2017.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Analyse de survie, Anticorps monoclonaux humanisés (usage thérapeutique), Coopération internationale, Facteurs de l'âge, Facteurs immunologiques (usage thérapeutique), Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Protéines Nogo (immunologie), Résultat thérapeutique, Sclérose latérale amyotrophique (mortalité), Sclérose latérale amyotrophique (traitement médicamenteux), Sujet âgé, Sujet âgé de 80 ans ou plus, Électrocardiographie.
- MESH :
- immunologie : Protéines Nogo.
- mortalité : Sclérose latérale amyotrophique.
- traitement médicamenteux : Sclérose latérale amyotrophique.
- usage thérapeutique : Anticorps monoclonaux humanisés, Facteurs immunologiques.
- Adolescent, Adulte, Adulte d'âge moyen, Analyse de survie, Coopération internationale, Facteurs de l'âge, Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Électrocardiographie.
English descriptors
- KwdEn :
- Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Amyotrophic Lateral Sclerosis (drug therapy), Amyotrophic Lateral Sclerosis (mortality), Antibodies, Monoclonal, Humanized (therapeutic use), Double-Blind Method, Electrocardiography, Female, Humans, Immunologic Factors (therapeutic use), International Cooperation, Male, Middle Aged, Nogo Proteins (immunology), Survival Analysis, Treatment Outcome, Young Adult.
- MESH :
- chemical , immunology : Nogo Proteins.
- chemical , therapeutic use : Antibodies, Monoclonal, Humanized, Immunologic Factors.
- drug therapy : Amyotrophic Lateral Sclerosis.
- mortality : Amyotrophic Lateral Sclerosis.
- Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Double-Blind Method, Electrocardiography, Female, Humans, International Cooperation, Male, Middle Aged, Survival Analysis, Treatment Outcome, Young Adult.
Abstract
Neurite outgrowth inhibitor A (Nogo-A) is thought to have a role in the pathophysiology of amyotrophic lateral sclerosis (ALS). A monoclonal antibody against Nogo-A showed a positive effect in the SOD1(G93A) mouse model of ALS, and a humanised form of this antibody (ozanezumab) was well tolerated in a first-in-human trial. Therefore, we aimed to assess the safety and efficacy of ozanezumab in patients with ALS.
DOI: 10.1016/S1474-4422(16)30399-4
PubMed: 28139349
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Kim</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, Hanyang University Medical Center, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Neurology, Hanyang University Medical Center, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Leigh, P Nigel" sort="Leigh, P Nigel" uniqKey="Leigh P" first="P Nigel" last="Leigh">P Nigel Leigh</name><affiliation wicri:level="4"><nlm:affiliation>Division of Medicine (Neurology), Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, University of Sussex, East Sussex, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Division of Medicine (Neurology), Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, University of Sussex, East Sussex</wicri:regionArea><orgName type="university">Université du Sussex</orgName><placeName><settlement type="city">Brighton</settlement><settlement type="town">Falmer</settlement><region type="nation">Angleterre</region><region nuts="2" type="region">Sussex de l'Est</region></placeName></affiliation></author><author><name sortKey="Kiernan, Matthew C" sort="Kiernan, Matthew C" uniqKey="Kiernan M" first="Matthew C" last="Kiernan">Matthew C. Kiernan</name><affiliation wicri:level="4"><nlm:affiliation>Brain & Mind Centre, Sydney Medical School, the University of Sydney, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Brain & Mind Centre, Sydney Medical School, the University of Sydney, Sydney, NSW</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Shefner, Jeremy M" sort="Shefner, Jeremy M" uniqKey="Shefner J" first="Jeremy M" last="Shefner">Jeremy M. Shefner</name><affiliation wicri:level="2"><nlm:affiliation>Barrow Neurological Institute, Phoenix, AZ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Barrow Neurological Institute, Phoenix, AZ</wicri:regionArea><placeName><region type="state">Arizona</region></placeName></affiliation></author><author><name sortKey="Desnuelle, Claude" sort="Desnuelle, Claude" uniqKey="Desnuelle C" first="Claude" last="Desnuelle">Claude Desnuelle</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, University Hospital of Nice, Nice, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Neurology, University Hospital of Nice, Nice</wicri:regionArea><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Morrison, Karen E" sort="Morrison, Karen E" uniqKey="Morrison K" first="Karen E" last="Morrison">Karen E. Morrison</name><affiliation wicri:level="4"><nlm:affiliation>Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Faculty of Medicine, University of Southampton, University Hospital Southampton, Southampton, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Faculty of Medicine, University of Southampton, University Hospital Southampton, Southampton</wicri:regionArea><orgName type="university">Université de Birmingham</orgName><placeName><settlement type="city">Birmingham</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Midlands de l'Ouest</region></placeName></affiliation></author><author><name sortKey="Petri, Susanne" sort="Petri, Susanne" uniqKey="Petri S" first="Susanne" last="Petri">Susanne Petri</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, Hannover Medical School, Hannover, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, Hannover Medical School, Hannover</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation></author><author><name sortKey="Boswell, Diane" sort="Boswell, Diane" uniqKey="Boswell D" first="Diane" last="Boswell">Diane Boswell</name><affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Temple, Jane" sort="Temple, Jane" uniqKey="Temple J" first="Jane" last="Temple">Jane Temple</name><affiliation wicri:level="1"><nlm:affiliation>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Mohindra, Rajat" sort="Mohindra, Rajat" uniqKey="Mohindra R" first="Rajat" last="Mohindra">Rajat Mohindra</name><affiliation wicri:level="1"><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Davies, Matt" sort="Davies, Matt" uniqKey="Davies M" first="Matt" last="Davies">Matt Davies</name><affiliation wicri:level="1"><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Bullman, Jonathan" sort="Bullman, Jonathan" uniqKey="Bullman J" first="Jonathan" last="Bullman">Jonathan Bullman</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage</wicri:regionArea><wicri:noRegion>Stevenage</wicri:noRegion></affiliation></author><author><name sortKey="Rees, Paul" sort="Rees, Paul" uniqKey="Rees P" first="Paul" last="Rees">Paul Rees</name><affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Lavrov, Arseniy" sort="Lavrov, Arseniy" uniqKey="Lavrov A" first="Arseniy" last="Lavrov">Arseniy Lavrov</name><affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK. Electronic address: arseniy.j.lavrov@gsk.com.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28139349</idno><idno type="pmid">28139349</idno><idno type="doi">10.1016/S1474-4422(16)30399-4</idno><idno type="wicri:Area/PubMed/Corpus">001024</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001024</idno><idno type="wicri:Area/PubMed/Curation">001021</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001021</idno><idno type="wicri:Area/PubMed/Checkpoint">001021</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001021</idno><idno type="wicri:Area/Ncbi/Merge">004240</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.</title><author><name sortKey="Meininger, Vincent" sort="Meininger, Vincent" uniqKey="Meininger V" first="Vincent" last="Meininger">Vincent Meininger</name><affiliation wicri:level="3"><nlm:affiliation>Ramsay Generale de Sante Hopital Prive Peupliers, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Ramsay Generale de Sante Hopital Prive Peupliers, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Genge, Angela" sort="Genge, Angela" uniqKey="Genge A" first="Angela" last="Genge">Angela Genge</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, QC, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, QC</wicri:regionArea><wicri:noRegion>QC</wicri:noRegion></affiliation></author><author><name sortKey="Van Den Berg, Leonard H" sort="Van Den Berg, Leonard H" uniqKey="Van Den Berg L" first="Leonard H" last="Van Den Berg">Leonard H. Van Den Berg</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, Brain Centre Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, Brain Centre Rudolf Magnus, University Medical Center Utrecht, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Robberecht, Wim" sort="Robberecht, Wim" uniqKey="Robberecht W" first="Wim" last="Robberecht">Wim Robberecht</name><affiliation wicri:level="1"><nlm:affiliation>KU Leuven, Department of Neurosciences, Experimental Neurology University Hospitals Leuven, Department of Neurology, Leuven, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>KU Leuven, Department of Neurosciences, Experimental Neurology University Hospitals Leuven, Department of Neurology, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Ludolph, Albert" sort="Ludolph, Albert" uniqKey="Ludolph A" first="Albert" last="Ludolph">Albert Ludolph</name><affiliation wicri:level="4"><nlm:affiliation>Department of Neurology, University of Ulm, Ulm, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, University of Ulm, 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><settlement type="city">Ulm</settlement></placeName><orgName type="university">Université d'Ulm</orgName></affiliation></author><author><name sortKey="Chio, Adriano" sort="Chio, Adriano" uniqKey="Chio A" first="Adriano" last="Chio">Adriano Chio</name><affiliation wicri:level="3"><nlm:affiliation>Rita Levi Montalcini Department of Neuroscience, University of Turin, Turin, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Rita Levi Montalcini Department of Neuroscience, University of Turin, Turin</wicri:regionArea><placeName><settlement type="city">Turin</settlement><region type="région" nuts="2">Piémont</region></placeName></affiliation></author><author><name sortKey="Kim, Seung H" sort="Kim, Seung H" uniqKey="Kim S" first="Seung H" last="Kim">Seung H. Kim</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, Hanyang University Medical Center, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Neurology, Hanyang University Medical Center, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Leigh, P Nigel" sort="Leigh, P Nigel" uniqKey="Leigh P" first="P Nigel" last="Leigh">P Nigel Leigh</name><affiliation wicri:level="4"><nlm:affiliation>Division of Medicine (Neurology), Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, University of Sussex, East Sussex, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Division of Medicine (Neurology), Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, University of Sussex, East Sussex</wicri:regionArea><orgName type="university">Université du Sussex</orgName><placeName><settlement type="city">Brighton</settlement><settlement type="town">Falmer</settlement><region type="nation">Angleterre</region><region nuts="2" type="region">Sussex de l'Est</region></placeName></affiliation></author><author><name sortKey="Kiernan, Matthew C" sort="Kiernan, Matthew C" uniqKey="Kiernan M" first="Matthew C" last="Kiernan">Matthew C. Kiernan</name><affiliation wicri:level="4"><nlm:affiliation>Brain & Mind Centre, Sydney Medical School, the University of Sydney, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Brain & Mind Centre, Sydney Medical School, the University of Sydney, Sydney, NSW</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Shefner, Jeremy M" sort="Shefner, Jeremy M" uniqKey="Shefner J" first="Jeremy M" last="Shefner">Jeremy M. Shefner</name><affiliation wicri:level="2"><nlm:affiliation>Barrow Neurological Institute, Phoenix, AZ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Barrow Neurological Institute, Phoenix, AZ</wicri:regionArea><placeName><region type="state">Arizona</region></placeName></affiliation></author><author><name sortKey="Desnuelle, Claude" sort="Desnuelle, Claude" uniqKey="Desnuelle C" first="Claude" last="Desnuelle">Claude Desnuelle</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, University Hospital of Nice, Nice, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Neurology, University Hospital of Nice, Nice</wicri:regionArea><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Morrison, Karen E" sort="Morrison, Karen E" uniqKey="Morrison K" first="Karen E" last="Morrison">Karen E. Morrison</name><affiliation wicri:level="4"><nlm:affiliation>Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Faculty of Medicine, University of Southampton, University Hospital Southampton, Southampton, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Faculty of Medicine, University of Southampton, University Hospital Southampton, Southampton</wicri:regionArea><orgName type="university">Université de Birmingham</orgName><placeName><settlement type="city">Birmingham</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Midlands de l'Ouest</region></placeName></affiliation></author><author><name sortKey="Petri, Susanne" sort="Petri, Susanne" uniqKey="Petri S" first="Susanne" last="Petri">Susanne Petri</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, Hannover Medical School, Hannover, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, Hannover Medical School, Hannover</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation></author><author><name sortKey="Boswell, Diane" sort="Boswell, Diane" uniqKey="Boswell D" first="Diane" last="Boswell">Diane Boswell</name><affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Temple, Jane" sort="Temple, Jane" uniqKey="Temple J" first="Jane" last="Temple">Jane Temple</name><affiliation wicri:level="1"><nlm:affiliation>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Mohindra, Rajat" sort="Mohindra, Rajat" uniqKey="Mohindra R" first="Rajat" last="Mohindra">Rajat Mohindra</name><affiliation wicri:level="1"><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Davies, Matt" sort="Davies, Matt" uniqKey="Davies M" first="Matt" last="Davies">Matt Davies</name><affiliation wicri:level="1"><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Bullman, Jonathan" sort="Bullman, Jonathan" uniqKey="Bullman J" first="Jonathan" last="Bullman">Jonathan Bullman</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage</wicri:regionArea><wicri:noRegion>Stevenage</wicri:noRegion></affiliation></author><author><name sortKey="Rees, Paul" sort="Rees, Paul" uniqKey="Rees P" first="Paul" last="Rees">Paul Rees</name><affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author><author><name sortKey="Lavrov, Arseniy" sort="Lavrov, Arseniy" uniqKey="Lavrov A" first="Arseniy" last="Lavrov">Arseniy Lavrov</name><affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK. Electronic address: arseniy.j.lavrov@gsk.com.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea><wicri:noRegion>Uxbridge</wicri:noRegion></affiliation></author></analytic><series><title level="j">The Lancet. Neurology</title><idno type="eISSN">1474-4465</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Age Factors</term><term>Aged</term><term>Aged, 80 and over</term><term>Amyotrophic Lateral Sclerosis (drug therapy)</term><term>Amyotrophic Lateral Sclerosis (mortality)</term><term>Antibodies, Monoclonal, Humanized (therapeutic use)</term><term>Double-Blind Method</term><term>Electrocardiography</term><term>Female</term><term>Humans</term><term>Immunologic Factors (therapeutic use)</term><term>International Cooperation</term><term>Male</term><term>Middle Aged</term><term>Nogo Proteins (immunology)</term><term>Survival Analysis</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Anticorps monoclonaux humanisés (usage thérapeutique)</term><term>Coopération internationale</term><term>Facteurs de l'âge</term><term>Facteurs immunologiques (usage thérapeutique)</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Protéines Nogo (immunologie)</term><term>Résultat thérapeutique</term><term>Sclérose latérale amyotrophique (mortalité)</term><term>Sclérose latérale amyotrophique (traitement médicamenteux)</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Électrocardiographie</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Nogo Proteins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Immunologic Factors</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Amyotrophic Lateral Sclerosis</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Protéines Nogo</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Amyotrophic Lateral Sclerosis</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Sclérose latérale amyotrophique</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Sclérose latérale amyotrophique</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Facteurs immunologiques</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Age Factors</term><term>Aged</term><term>Aged, 80 and over</term><term>Double-Blind Method</term><term>Electrocardiography</term><term>Female</term><term>Humans</term><term>International Cooperation</term><term>Male</term><term>Middle Aged</term><term>Survival Analysis</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Coopération internationale</term><term>Facteurs de l'âge</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Électrocardiographie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Neurite outgrowth inhibitor A (Nogo-A) is thought to have a role in the pathophysiology of amyotrophic lateral sclerosis (ALS). A monoclonal antibody against Nogo-A showed a positive effect in the SOD1(G93A) mouse model of ALS, and a humanised form of this antibody (ozanezumab) was well tolerated in a first-in-human trial. Therefore, we aimed to assess the safety and efficacy of ozanezumab in patients with ALS.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28139349</PMID><DateCreated><Year>2017</Year><Month>01</Month><Day>31</Day></DateCreated><DateCompleted><Year>2017</Year><Month>05</Month><Day>30</Day></DateCompleted><DateRevised><Year>2017</Year><Month>07</Month><Day>27</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-4465</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><Issue>3</Issue><PubDate><Year>2017</Year><Month>03</Month></PubDate></JournalIssue><Title>The Lancet. Neurology</Title><ISOAbbreviation>Lancet Neurol</ISOAbbreviation></Journal><ArticleTitle>Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.</ArticleTitle><Pagination><MedlinePgn>208-216</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1474-4422(16)30399-4</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1474-4422(16)30399-4</ELocationID><Abstract><AbstractText Label="BACKGROUND">Neurite outgrowth inhibitor A (Nogo-A) is thought to have a role in the pathophysiology of amyotrophic lateral sclerosis (ALS). A monoclonal antibody against Nogo-A showed a positive effect in the SOD1(G93A) mouse model of ALS, and a humanised form of this antibody (ozanezumab) was well tolerated in a first-in-human trial. Therefore, we aimed to assess the safety and efficacy of ozanezumab in patients with ALS.</AbstractText><AbstractText Label="METHODS">This randomised, double-blind, placebo-controlled, phase 2 trial was done in 34 centres in 11 countries. Patients aged 18-80 years with a diagnosis of familial or sporadic ALS were randomly assigned (1:1), centrally according to a computer-generated allocation schedule, to receive ozanezumab (15 mg/kg) or placebo as intravenous infusions over 1 h every 2 weeks for 46 weeks, followed by assessments at week 48 and week 60. Patients and study personnel were masked to treatment assignment. The primary outcome was a joint-rank analysis of function (ALS Functional Rating Scale-Revised) and overall survival, analysed at 48 weeks in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT01753076, and with GSK-ClinicalStudyRegister.com, NOG112264, and is completed.</AbstractText><AbstractText Label="FINDINGS">Between Dec 20, 2012, and Nov 1, 2013, we recruited 307 patients, of whom 303 were randomly assigned to receive placebo (n=151) or ozanezumab (n=152). The adjusted mean of the joint-rank score was -14·9 (SE 13·5) for the ozanezumab group and 15·0 (13·6) for the placebo group, with a least squares mean difference of -30·0 (95% CI -67·9 to 7·9; p=0·12). Overall, reported adverse events, serious adverse events, and adverse events leading to permanent discontinuation of study drug or withdrawal from study were similar between the treatment groups, except for dyspepsia (ten [7%] in the ozanezumab group vs four [3%] in the placebo group), depression (11 [7%] vs five [3%]), and diarrhoea (25 [16%] vs 12 [8%]). Respiratory failure was the most common serious adverse event (12 [8%] vs seven [5%]). At week 60, the number of deaths was higher in the ozanezumab group (20 [13%]) than in the placebo group (16 [11%]), mainly as a result of respiratory failure (ten [7%] vs five [3%]). Two deaths were considered related to the study drug (bladder transitional cell carcinoma in the ozanezumab group and cerebrovascular accident in the placebo group).</AbstractText><AbstractText Label="INTERPRETATION">Ozanezumab did not show efficacy compared with placebo in patients with ALS. Therefore, Nogo-A does not seem to be an effective therapeutic target in ALS.</AbstractText><AbstractText Label="FUNDING">GlaxoSmithKline.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Meininger</LastName><ForeName>Vincent</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Ramsay Generale de Sante Hopital Prive Peupliers, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Genge</LastName><ForeName>Angela</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, QC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van den Berg</LastName><ForeName>Leonard H</ForeName><Initials>LH</Initials><AffiliationInfo><Affiliation>Department of Neurology, Brain Centre Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robberecht</LastName><ForeName>Wim</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>KU Leuven, Department of Neurosciences, Experimental Neurology University Hospitals Leuven, Department of Neurology, Leuven, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ludolph</LastName><ForeName>Albert</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Neurology, University of Ulm, Ulm, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chio</LastName><ForeName>Adriano</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Rita Levi Montalcini Department of Neuroscience, University of Turin, Turin, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Seung H</ForeName><Initials>SH</Initials><AffiliationInfo><Affiliation>Department of Neurology, Hanyang University Medical Center, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leigh</LastName><ForeName>P Nigel</ForeName><Initials>PN</Initials><AffiliationInfo><Affiliation>Division of Medicine (Neurology), Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, University of Sussex, East Sussex, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kiernan</LastName><ForeName>Matthew C</ForeName><Initials>MC</Initials><AffiliationInfo><Affiliation>Brain & Mind Centre, Sydney Medical School, the University of Sydney, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shefner</LastName><ForeName>Jeremy M</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Barrow Neurological Institute, Phoenix, AZ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Desnuelle</LastName><ForeName>Claude</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Neurology, University Hospital of Nice, Nice, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morrison</LastName><ForeName>Karen E</ForeName><Initials>KE</Initials><AffiliationInfo><Affiliation>Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Faculty of Medicine, University of Southampton, University Hospital Southampton, Southampton, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Petri</LastName><ForeName>Susanne</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Neurology, Hannover Medical School, Hannover, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boswell</LastName><ForeName>Diane</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Temple</LastName><ForeName>Jane</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mohindra</LastName><ForeName>Rajat</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Davies</LastName><ForeName>Matt</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bullman</LastName><ForeName>Jonathan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rees</LastName><ForeName>Paul</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lavrov</LastName><ForeName>Arseniy</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK. Electronic address: arseniy.j.lavrov@gsk.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>NOG112264 Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>01</Month><Day>28</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Neurol</MedlineTA><NlmUniqueID>101139309</NlmUniqueID><ISSNLinking>1474-4422</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007155">Immunologic Factors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000070798">Nogo Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>123I05210W</RegistryNumber><NameOfSubstance UI="C000594256">ozanezumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000367" MajorTopicYN="N">Age Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000690" MajorTopicYN="N">Amyotrophic Lateral Sclerosis</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D061067" MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004562" MajorTopicYN="N">Electrocardiography</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007155" MajorTopicYN="N">Immunologic Factors</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007391" MajorTopicYN="N">International Cooperation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000070798" MajorTopicYN="N">Nogo Proteins</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016019" MajorTopicYN="N">Survival Analysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="Y">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>Abdulla</LastName><ForeName>Susanne</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Alsop</LastName><ForeName>Cathy</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Barbieri</LastName><ForeName>Francesca</ForeName><Initials>F</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bates</LastName><ForeName>Stewart</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Berry</LastName><ForeName>James D</ForeName><Initials>JD</Initials></Investigator><Investigator ValidYN="Y"><LastName>Botez</LastName><ForeName>Stephan A</ForeName><Initials>SA</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bruneteau</LastName><ForeName>Gaelle</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Calvo</LastName><ForeName>Andrea</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Camejo</LastName><ForeName>Rodrigo Refoios</ForeName><Initials>RR</Initials></Investigator><Investigator ValidYN="Y"><LastName>Camu</LastName><ForeName>William</ForeName><Initials>W</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chauhan</LastName><ForeName>Deven</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Danel-Brunaud</LastName><ForeName>Veronique</ForeName><Initials>V</Initials></Investigator><Investigator ValidYN="Y"><LastName>Daniluk</LastName><ForeName>Jerzy</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Dekker</LastName><ForeName>Annelot</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Destee</LastName><ForeName>Alain</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Devine</LastName><ForeName>Matthew</ForeName><Initials>M</Initials></Investigator><Investigator 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Morrison</name><name sortKey="Rees, Paul" sort="Rees, Paul" uniqKey="Rees P" first="Paul" last="Rees">Paul Rees</name><name sortKey="Temple, Jane" sort="Temple, Jane" uniqKey="Temple J" first="Jane" last="Temple">Jane Temple</name></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Kiernan, Matthew C" sort="Kiernan, Matthew C" uniqKey="Kiernan M" first="Matthew C" last="Kiernan">Matthew C. Kiernan</name></region></country><country name="États-Unis"><region name="Arizona"><name sortKey="Shefner, Jeremy M" sort="Shefner, Jeremy M" uniqKey="Shefner J" first="Jeremy M" last="Shefner">Jeremy M. Shefner</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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