{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T01:22:49Z","timestamp":1787966569325,"version":"build-2784847793"},"reference-count":33,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2015,12,14]],"date-time":"2015-12-14T00:00:00Z","timestamp":1450051200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>To date, no treatment for neuromyelitis optica (NMO) has been granted regulatory approval, and no controlled clinical studies have been reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To design a placebo-controlled study in NMO that appropriately balances patient safety and clinical\u2013scientific integrity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We assessed the \u201cstandard of care\u201d for NMO to establish the ethical framework for a placebo-controlled trial. We implemented measures that balance the need for scientific robustness while mitigating the risks associated with a placebo-controlled study. The medical or scientific community, patient organizations, and regulatory authorities were engaged early in discussions on this placebo-controlled study, and their input contributed to the final study design.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The N-MOmentum study (NCT02200770) is a clinical trial that randomizes NMO patients to receive MEDI-551, a monoclonal antibody that depletes CD19+ B-cells, or placebo. The study design has received regulatory, ethical, clinical, and patient approval in over 100 clinical sites in more than 20 countries worldwide.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The approach we took in the design of the N-MOmentum trial might serve as a roadmap for other rare severe diseases when there is no proven therapy and no established clinical development path.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1352458515620934","type":"journal-article","created":{"date-parts":[[2015,12,14]],"date-time":"2015-12-14T22:23:36Z","timestamp":1450131816000},"page":"862-872","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":69,"title":["Placebo-controlled study in neuromyelitis optica\u2014Ethical and design considerations"],"prefix":"10.1177","volume":"22","author":[{"given":"Bruce AC","family":"Cree","sequence":"first","affiliation":[{"name":"Multiple Sclerosis Center, Department of Neurology, University of California San Francisco, San Francisco, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey L","family":"Bennett","sequence":"additional","affiliation":[{"name":"Program in Neuroscience, Departments of Neurology and Ophthalmology, University of Colorado, Denver, CO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Sheehan","sequence":"additional","affiliation":[{"name":"The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Cohen","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-Peter","family":"Hartung","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, Heinrich Heine University D\u00fcsseldorf, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orhan","family":"Aktas","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, Heinrich Heine University D\u00fcsseldorf, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ho Jin","family":"Kim","sequence":"additional","affiliation":[{"name":"Research Institute and Hospital of National Cancer Center, Goyang, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Friedemann","family":"Paul","sequence":"additional","affiliation":[{"name":"Charite\u2014University Medicine Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Pittock","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, MN, 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