{"data":{"id":"10.25384/sage.c.4486853","type":"dois","attributes":{"doi":"10.25384/sage.c.4486853","prefix":"10.25384","suffix":"sage.c.4486853","identifiers":[],"alternateIdentifiers":[],"creators":[{"name":"Hardan, Antonio Y","nameType":"Personal","givenName":"Antonio Y","familyName":"Hardan","affiliation":[],"nameIdentifiers":[]},{"name":"Hendren, Robert L","nameType":"Personal","givenName":"Robert L","familyName":"Hendren","affiliation":[],"nameIdentifiers":[]},{"name":"Aman, Michael G","nameType":"Personal","givenName":"Michael G","familyName":"Aman","affiliation":[],"nameIdentifiers":[]},{"name":"Robb, Adelaide","nameType":"Personal","givenName":"Adelaide","familyName":"Robb","affiliation":[],"nameIdentifiers":[]},{"name":"Melmed, Raun D","nameType":"Personal","givenName":"Raun D","familyName":"Melmed","affiliation":[],"nameIdentifiers":[]},{"name":"Andersen, Kristen A","nameType":"Personal","givenName":"Kristen A","familyName":"Andersen","affiliation":[],"nameIdentifiers":[]},{"name":"Luchini, Rachel","nameType":"Personal","givenName":"Rachel","familyName":"Luchini","affiliation":[],"nameIdentifiers":[]},{"name":"Rezwanur Rahman","affiliation":[],"nameIdentifiers":[]},{"name":"Sanjida Ali","affiliation":[],"nameIdentifiers":[]},{"name":"X Daniel Jia","affiliation":[],"nameIdentifiers":[]},{"name":"Madhuja Mallick","affiliation":[],"nameIdentifiers":[]},{"name":"Lateiner, Jordan E","nameType":"Personal","givenName":"Jordan E","familyName":"Lateiner","affiliation":[],"nameIdentifiers":[]},{"name":"Palmer, Robert H","nameType":"Personal","givenName":"Robert H","familyName":"Palmer","affiliation":[],"nameIdentifiers":[]},{"name":"Graham, Stephen M","nameType":"Personal","givenName":"Stephen M","familyName":"Graham","affiliation":[],"nameIdentifiers":[]}],"titles":[{"title":"Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies"}],"publisher":"Figshare","container":{},"publicationYear":2019,"subjects":[{"subject":"170199 Psychology not elsewhere classified","subjectScheme":"FOR"},{"subject":"FOS: Psychology","schemeUri":"http://www.oecd.org/science/inno/38235147.pdf","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"110319 Psychiatry (incl. Psychotherapy)","subjectScheme":"FOR"},{"subject":"FOS: Clinical medicine","schemeUri":"http://www.oecd.org/science/inno/38235147.pdf","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"111799 Public Health and Health Services not elsewhere classified","subjectScheme":"FOR"},{"subject":"FOS: Health sciences","schemeUri":"http://www.oecd.org/science/inno/38235147.pdf","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"Education"},{"subject":"130312 Special Education and Disability","subjectScheme":"FOR"},{"subject":"FOS: Educational sciences","schemeUri":"http://www.oecd.org/science/inno/38235147.pdf","subjectScheme":"Fields of Science and Technology (FOS)"}],"contributors":[],"dates":[{"date":"2019-04-29","dateType":"Created"},{"date":"2019-04-29","dateType":"Updated"},{"date":"2019","dateType":"Issued"}],"language":null,"types":{"ris":"GEN","bibtex":"misc","citeproc":"article","schemaOrg":"Collection","resourceType":"Collection","resourceTypeGeneral":"Collection"},"relatedIdentifiers":[{"relationType":"IsSupplementTo","relatedIdentifier":"10.1177/1362361318824103","relatedIdentifierType":"DOI"}],"relatedItems":[],"sizes":[],"formats":[],"version":null,"rightsList":[{"rights":"CC BY 4.0","rightsUri":"https://creativecommons.org/licenses/by/4.0"}],"descriptions":[{"description":"Three phase 2 trials were conducted to assess the efficacy and long-term safety of weight-based memantine extended release (ER) treatment in children with autism spectrum disorder. MEM-MD-91, a 50-week open-label trial, identified memantine extended-release treatment responders for enrollment into MEM-MD-68, a 12-week randomized, double-blind, placebo-controlled withdrawal trial. MEM-MD-69 was an open-label extension trial in which participants from MEM-MD-68, MEM-MD-91, and open-label trial MEM-MD-67 were treated ⩽48 weeks with memantine extended release. In MEM-MD-91, 517 (59.6%) participants were confirmed Social Responsiveness Scale responders at week 12; mean Social Responsiveness Scale total raw scores improved two to three times a minimal clinically important difference of 10 points. In MEM-MD-68, there was no difference between memantine and placebo on the primary efficacy parameter, the proportion of patients with a loss of therapeutic response (defined as ⩾10-point increase from baseline in Social Responsiveness Scale total raw score). MEM-MD-69 exploratory analyses revealed mean standard deviation improvement in Social Responsiveness Scale total raw score of 32.4 (26.4) from baseline of the first lead-in study. No new safety concerns were evident. While the a priori–defined efficacy results of the double-blind trial were not achieved, the considerable improvements in mean Social Responsiveness Scale scores from baseline in the open-label trials were presumed to be clinically important.","descriptionType":"Abstract"}],"geoLocations":[],"fundingReferences":[],"xml":"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