Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.
Identifieur interne : 000049 ( PubMed/Corpus ); précédent : 000048; suivant : 000050Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.
Auteurs : Vincent Meininger ; Angela Genge ; Leonard H. Van Den Berg ; Wim Robberecht ; Albert Ludolph ; Adriano Chio ; Seung H. Kim ; P Nigel Leigh ; Matthew C. Kiernan ; Jeremy M. Shefner ; Claude Desnuelle ; Karen E. Morrison ; Susanne Petri ; Diane Boswell ; Jane Temple ; Rajat Mohindra ; Matt Davies ; Jonathan Bullman ; Paul Rees ; Arseniy LavrovSource :
- The Lancet. Neurology [ 1474-4465 ] ; 2017.
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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<record><TEI><teiHeader><fileDesc><titleStmt><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><nlm:affiliation>Ramsay Generale de Sante Hopital Prive Peupliers, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Genge, Angela" sort="Genge, Angela" uniqKey="Genge A" first="Angela" last="Genge">Angela Genge</name><affiliation><nlm:affiliation>Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, QC, Canada.</nlm:affiliation></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><nlm:affiliation>Department of Neurology, Brain Centre Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Robberecht, Wim" sort="Robberecht, Wim" uniqKey="Robberecht W" first="Wim" last="Robberecht">Wim Robberecht</name><affiliation><nlm:affiliation>KU Leuven, Department of Neurosciences, Experimental Neurology University Hospitals Leuven, Department of Neurology, Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Ludolph, Albert" sort="Ludolph, Albert" uniqKey="Ludolph A" first="Albert" last="Ludolph">Albert Ludolph</name><affiliation><nlm:affiliation>Department of Neurology, University of Ulm, Ulm, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Chio, Adriano" sort="Chio, Adriano" uniqKey="Chio A" first="Adriano" last="Chio">Adriano Chio</name><affiliation><nlm:affiliation>Rita Levi Montalcini Department of Neuroscience, University of Turin, Turin, Italy.</nlm:affiliation></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><nlm:affiliation>Department of Neurology, Hanyang University Medical Center, Seoul, South Korea.</nlm:affiliation></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><nlm:affiliation>Division of Medicine (Neurology), Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, University of Sussex, East Sussex, UK.</nlm:affiliation></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><nlm:affiliation>Brain & Mind Centre, Sydney Medical School, the University of Sydney, Sydney, NSW, Australia.</nlm:affiliation></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><nlm:affiliation>Barrow Neurological Institute, Phoenix, AZ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Desnuelle, Claude" sort="Desnuelle, Claude" uniqKey="Desnuelle C" first="Claude" last="Desnuelle">Claude Desnuelle</name><affiliation><nlm:affiliation>Department of Neurology, University Hospital of Nice, Nice, France.</nlm:affiliation></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><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></affiliation></author><author><name sortKey="Petri, Susanne" sort="Petri, Susanne" uniqKey="Petri S" first="Susanne" last="Petri">Susanne Petri</name><affiliation><nlm:affiliation>Department of Neurology, Hannover Medical School, Hannover, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Boswell, Diane" sort="Boswell, Diane" uniqKey="Boswell D" first="Diane" last="Boswell">Diane Boswell</name><affiliation><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Temple, Jane" sort="Temple, Jane" uniqKey="Temple J" first="Jane" last="Temple">Jane Temple</name><affiliation><nlm:affiliation>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mohindra, Rajat" sort="Mohindra, Rajat" uniqKey="Mohindra R" first="Rajat" last="Mohindra">Rajat Mohindra</name><affiliation><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Davies, Matt" sort="Davies, Matt" uniqKey="Davies M" first="Matt" last="Davies">Matt Davies</name><affiliation><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Bullman, Jonathan" sort="Bullman, Jonathan" uniqKey="Bullman J" first="Jonathan" last="Bullman">Jonathan Bullman</name><affiliation><nlm:affiliation>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Rees, Paul" sort="Rees, Paul" uniqKey="Rees P" first="Paul" last="Rees">Paul Rees</name><affiliation><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Lavrov, Arseniy" sort="Lavrov, Arseniy" uniqKey="Lavrov A" first="Arseniy" last="Lavrov">Arseniy Lavrov</name><affiliation><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK. Electronic address: arseniy.j.lavrov@gsk.com.</nlm:affiliation></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">000049</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000049</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><nlm:affiliation>Ramsay Generale de Sante Hopital Prive Peupliers, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Genge, Angela" sort="Genge, Angela" uniqKey="Genge A" first="Angela" last="Genge">Angela Genge</name><affiliation><nlm:affiliation>Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, QC, Canada.</nlm:affiliation></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><nlm:affiliation>Department of Neurology, Brain Centre Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Robberecht, Wim" sort="Robberecht, Wim" uniqKey="Robberecht W" first="Wim" last="Robberecht">Wim Robberecht</name><affiliation><nlm:affiliation>KU Leuven, Department of Neurosciences, Experimental Neurology University Hospitals Leuven, Department of Neurology, Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Ludolph, Albert" sort="Ludolph, Albert" uniqKey="Ludolph A" first="Albert" last="Ludolph">Albert Ludolph</name><affiliation><nlm:affiliation>Department of Neurology, University of Ulm, Ulm, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Chio, Adriano" sort="Chio, Adriano" uniqKey="Chio A" first="Adriano" last="Chio">Adriano Chio</name><affiliation><nlm:affiliation>Rita Levi Montalcini Department of Neuroscience, University of Turin, Turin, Italy.</nlm:affiliation></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><nlm:affiliation>Department of Neurology, Hanyang University Medical Center, Seoul, South Korea.</nlm:affiliation></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><nlm:affiliation>Division of Medicine (Neurology), Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, University of Sussex, East Sussex, UK.</nlm:affiliation></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><nlm:affiliation>Brain & Mind Centre, Sydney Medical School, the University of Sydney, Sydney, NSW, Australia.</nlm:affiliation></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><nlm:affiliation>Barrow Neurological Institute, Phoenix, AZ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Desnuelle, Claude" sort="Desnuelle, Claude" uniqKey="Desnuelle C" first="Claude" last="Desnuelle">Claude Desnuelle</name><affiliation><nlm:affiliation>Department of Neurology, University Hospital of Nice, Nice, France.</nlm:affiliation></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><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></affiliation></author><author><name sortKey="Petri, Susanne" sort="Petri, Susanne" uniqKey="Petri S" first="Susanne" last="Petri">Susanne Petri</name><affiliation><nlm:affiliation>Department of Neurology, Hannover Medical School, Hannover, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Boswell, Diane" sort="Boswell, Diane" uniqKey="Boswell D" first="Diane" last="Boswell">Diane Boswell</name><affiliation><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Temple, Jane" sort="Temple, Jane" uniqKey="Temple J" first="Jane" last="Temple">Jane Temple</name><affiliation><nlm:affiliation>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mohindra, Rajat" sort="Mohindra, Rajat" uniqKey="Mohindra R" first="Rajat" last="Mohindra">Rajat Mohindra</name><affiliation><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Davies, Matt" sort="Davies, Matt" uniqKey="Davies M" first="Matt" last="Davies">Matt Davies</name><affiliation><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Bullman, Jonathan" sort="Bullman, Jonathan" uniqKey="Bullman J" first="Jonathan" last="Bullman">Jonathan Bullman</name><affiliation><nlm:affiliation>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Rees, Paul" sort="Rees, Paul" uniqKey="Rees P" first="Paul" last="Rees">Paul Rees</name><affiliation><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Lavrov, Arseniy" sort="Lavrov, Arseniy" uniqKey="Lavrov A" first="Arseniy" last="Lavrov">Arseniy Lavrov</name><affiliation><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK. Electronic address: arseniy.j.lavrov@gsk.com.</nlm:affiliation></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></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="In-Process" Owner="NLM"><PMID Version="1">28139349</PMID><DateCreated><Year>2017</Year><Month>01</Month><Day>31</Day></DateCreated><DateRevised><Year>2017</Year><Month>05</Month><Day>02</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="D016428">Journal Article</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><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 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