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ERIC Number: EJ1230612
Record Type: Journal
Publication Date: 2019-Nov
Pages: 16
Abstractor: As Provided
ISBN: N/A
ISSN: ISSN-1362-3613
EISSN: N/A
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: The International Journal of Research and Practice, v23 n8 p2096-2111 Nov 2019
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. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: http://sagepub.com
Publication Type: Journal Articles; Reports - Research
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A
Identifiers - Assessments and Surveys: Social Responsiveness Scale
Grant or Contract Numbers: N/A