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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2019
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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. |
format | Online Article Text |
id | pubmed-6779018 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
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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