Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies. (November 2019)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Autism. Volume 23:Number 8(2019)
• Page Start: 2096
• Page End: 2111
• Publication Date: 2019-11
• Subjects: Asperger's disorder -- autism spectrum disorders -- clinical trial -- medication -- memantine -- pervasive developmental disorder-not otherwise specified -- randomized withdrawal -- school-age children -- Social Responsiveness Scale; Autism -- Periodicals; Autism in children -- Periodicals; 616.85882005
• DOI: 10.1177/1362361318824103
• Languages: English
• ISSNs: 1362-3613

Abstract

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.