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Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies

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 M...

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Autores principales: Hardan, Antonio Y, Hendren, Robert L, Aman, Michael G, Robb, Adelaide, Melmed, Raun D, Andersen, Kristen A, Luchini, Rachel, Rahman, Rezwanur, Ali, Sanjida, Jia, X Daniel, Mallick, Madhuja, Lateiner, Jordan E, Palmer, Robert H, Graham, Stephen M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6779018/
https://www.ncbi.nlm.nih.gov/pubmed/31027422
http://dx.doi.org/10.1177/1362361318824103
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author Hardan, Antonio Y
Hendren, Robert L
Aman, Michael G
Robb, Adelaide
Melmed, Raun D
Andersen, Kristen A
Luchini, Rachel
Rahman, Rezwanur
Ali, Sanjida
Jia, X Daniel
Mallick, Madhuja
Lateiner, Jordan E
Palmer, Robert H
Graham, Stephen M
author_facet Hardan, Antonio Y
Hendren, Robert L
Aman, Michael G
Robb, Adelaide
Melmed, Raun D
Andersen, Kristen A
Luchini, Rachel
Rahman, Rezwanur
Ali, Sanjida
Jia, X Daniel
Mallick, Madhuja
Lateiner, Jordan E
Palmer, Robert H
Graham, Stephen M
author_sort Hardan, Antonio Y
collection PubMed
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.
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spelling pubmed-67790182019-10-23 Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies Hardan, Antonio Y Hendren, Robert L Aman, Michael G Robb, Adelaide Melmed, Raun D Andersen, Kristen A Luchini, Rachel Rahman, Rezwanur Ali, Sanjida Jia, X Daniel Mallick, Madhuja Lateiner, Jordan E Palmer, Robert H Graham, Stephen M Autism Original Articles 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. SAGE Publications 2019-04-26 2019-11 /pmc/articles/PMC6779018/ /pubmed/31027422 http://dx.doi.org/10.1177/1362361318824103 Text en © The Author(s) 2019 http://www.creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Articles
Hardan, Antonio Y
Hendren, Robert L
Aman, Michael G
Robb, Adelaide
Melmed, Raun D
Andersen, Kristen A
Luchini, Rachel
Rahman, Rezwanur
Ali, Sanjida
Jia, X Daniel
Mallick, Madhuja
Lateiner, Jordan E
Palmer, Robert H
Graham, Stephen M
Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies
title Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies
title_full Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies
title_fullStr Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies
title_full_unstemmed Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies
title_short Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies
title_sort efficacy and safety of memantine in children with autism spectrum disorder: results from three phase 2 multicenter studies
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6779018/
https://www.ncbi.nlm.nih.gov/pubmed/31027422
http://dx.doi.org/10.1177/1362361318824103
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