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Open Access
Peer-reviewed
Research Article
Safety, Pharmacokinetic, and Functional Effects of the Nogo-A Monoclonal Antibody in Amyotrophic Lateral Sclerosis: A Randomized, First-In-Human Clinical Trial
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Vincent Meininger,
Affiliation Département des Maladies du Système Nerveux, Assistance Publique – Hôpitaux de Paris, Centre de Référence Maladies Rares SLA, Groupe Hospitalier Pitié-Salpêtrière, Université Pierre-et-Marie-Curie, Paris, France
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Pierre-François Pradat,
Affiliations Département des Maladies du Système Nerveux, Assistance Publique – Hôpitaux de Paris, Centre de Référence Maladies Rares SLA, Groupe Hospitalier Pitié-Salpêtrière, Université Pierre-et-Marie-Curie, Paris, France, Unité Mixte de Recherche-678, Institut National de la Santé et de la Recherche Médicale - Université Pierre-et-Marie-Curie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
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Andrea Corse,
Affiliation Neuromuscular Pathology Lab, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America
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Safa Al-Sarraj,
Affiliation Department of Clinical Neuropathology, Kings College Hospital/Kings College London, London, United Kingdom
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Benjamin Rix Brooks,
Affiliation Carolinas Neuromuscular/Amyotrophic Lateral Sclerosis-Muscular Dystrophy Association Center, Department of Neurology, Carolinas Medical Center and University of North Carolina School of Medicine-Charlotte Campus, Charlotte, North Carolina, United States of America
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James B. Caress,
Affiliation Wake Forest School of Medicine, M Reynolds Tower, Medical Center Boulevard, Winston-Salem, North Carolina, United States of America
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Merit Cudkowicz,
Affiliation Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States of America
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Stephen J. Kolb,
Affiliation Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America
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Dale Lange,
Affiliation Department of Neurology, Weill Cornell School of Medicine, New York, New York, United States of America
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P. Nigel Leigh,
Affiliation Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, Falmer, Sussex, United Kingdom
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Thomas Meyer,
Affiliation Department of Neurology, Charité – Universitätsmedizin Berlin, Berlin, Germany
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Stefano Milleri,
Affiliation Centro Ricerche Cliniche, University Hospital G.B. Rossi, Verona, Italy
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Karen E. Morrison,
Affiliation School of Clinical and Experimental Medicine, University of Birmingham and Neurosciences Department, Queen Elizabeth Hospital, Birmingham, United Kingdom
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Richard W. Orrell,
Affiliations Department of Clinical Neuroscience, Institute of Neurology, University College London, London, United Kingdom, Department of Neurology, Royal Free London NHS Foundation Trust, London, United Kingdom
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Gary Peters,
Affiliation GlaxoSmithKline Clinical Unit Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom
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Jeffrey D. Rothstein,
Affiliation Brain Science Institute, Johns Hopkins University, Department of Neurology, Baltimore, Maryland, United States of America
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Jeremy Shefner,
Affiliation Department of Neurology, SUNY Upstate Medical University, Syracuse, New York, United States of America
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Arseniy Lavrov ,
* E-mail: arseniy.j.lavrov@gsk.com
Affiliation Neurosciences Therapy Area Unit, Medicines Discovery and Development, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, United Kingdom
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Nicola Williams,
Affiliation Clinical Statistics, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom
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Phil Overend,
Affiliation Clinical Statistics, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom
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Jeffrey Price,
Affiliation Clinical Pharmacology, Science and Study Operations, BioPharm and Infectious Diseases, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom
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Stewart Bates,
Affiliation BioPharm Translational Medicine, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom
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Jonathan Bullman,
Affiliation Clinical Pharmacology Modelling & Simulation (Neurosciences), GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom
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David Krull,
Affiliation Safety Assessment, GlaxoSmithKline, Research Triangle Park, North Carolina, United States of America
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Alienor Berges,
Affiliation Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, United Kingdom
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Bams Abila,
Affiliation BioPharm Translational Medicine, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom
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Guy Meno-Tetang,
Affiliation Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, United Kingdom
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Jens Wurthner
Affiliation Oncology Translational Medicine, Novartis Basel, Switzerland
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Safety, Pharmacokinetic, and Functional Effects of the Nogo-A Monoclonal Antibody in Amyotrophic Lateral Sclerosis: A Randomized, First-In-Human Clinical Trial
- Vincent Meininger,
- Pierre-François Pradat,
- Andrea Corse,
- Safa Al-Sarraj,
- Benjamin Rix Brooks,
- James B. Caress,
- Merit Cudkowicz,
- Stephen J. Kolb,
- Dale Lange,
- P. Nigel Leigh
- Published: May 19, 2014
- https://doi.org/10.1371/journal.pone.0097803