Efficacy and Safety of Memantine in Children with Autism Spectrum Disorder: Results from Three Phase 2 Multicenter Studies

Autor/inn/en	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.
Titel	Efficacy and Safety of Memantine in Children with Autism Spectrum Disorder: Results from Three Phase 2 Multicenter Studies
Quelle	In: Autism: The International Journal of Research and Practice, 23 (2019) 8, S.2096-2111 (16 Seiten) PDF als Volltext Verfügbarkeit
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	1362-3613
DOI	10.1177/1362361318824103
Schlagwörter	Children; Autism; Pervasive Developmental Disorders; Drug Therapy; Outcomes of Treatment; Asperger Syndrome; Safety; Intervention; Randomized Controlled Trials; Social Responsiveness Scale + Suchen Sie Ihr Suchwort? Child; Kind; Kinder; Autismus; Asperger-Syndrom; Sicherheit
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. (As Provided).
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Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2020/1/01