Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies / A. Y. HARDAN in Autism, 23-8 (November 2019)  

Public ISBD [article]  inAutism > 23-8 (November 2019) . - p.2096-2111 Titre : Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies Type de document : Texte imprimé et/ou numérique Auteurs : A. Y. HARDAN, Auteur ; R. L. HENDREN, Auteur ; Michael G. AMAN, Auteur ; A. ROBB, Auteur ; R. D. MELMED, Auteur ; K. A. ANDERSEN, Auteur ; R. LUCHINI, Auteur ; R. RAHMAN, Auteur ; S. ALI, Auteur ; X. D. JIA, Auteur ; M. MALLICK, Auteur ; J. E. LATEINER, Auteur ; Rohan H. C. PALMER, Auteur ; S. M. GRAHAM, Auteur Article en page(s) : p.2096-2111 Langues : Anglais (eng) Mots-clés : Asperger's disorder  Social Responsiveness Scale  autism spectrum disorders  clinical trial  medication  memantine  pervasive developmental disorder-not otherwise specified  randomized withdrawal  school-age children Index. décimale : PER Périodiques Résumé : 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. En ligne : http://dx.doi.org/10.1177/1362361318824103 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=407 [article] Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies [Texte imprimé et/ou numérique] / A. Y. HARDAN, Auteur ; R. L. HENDREN, Auteur ; Michael G. AMAN, Auteur ; A. ROBB, Auteur ; R. D. MELMED, Auteur ; K. A. ANDERSEN, Auteur ; R. LUCHINI, Auteur ; R. RAHMAN, Auteur ; S. ALI, Auteur ; X. D. JIA, Auteur ; M. MALLICK, Auteur ; J. E. LATEINER, Auteur ; Rohan H. C. PALMER, Auteur ; S. M. GRAHAM, Auteur . - p.2096-2111. Langues : Anglais (eng) in Autism > 23-8 (November 2019) . - p.2096-2111 Mots-clés : Asperger's disorder  Social Responsiveness Scale  autism spectrum disorders  clinical trial  medication  memantine  pervasive developmental disorder-not otherwise specified  randomized withdrawal  school-age children Index. décimale : PER Périodiques Résumé : 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. En ligne : http://dx.doi.org/10.1177/1362361318824103 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=407

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