PT  - JOURNAL ARTICLE
AU  - Katz, Ephraim
AU  - Lateiner, Jordan
AU  - Spera, Allan
AU  - Palmer, Robert
AU  - Graham, Stephen
TI  - Memantine for the Treatment of Autism Spectrum Disorder: Overview of the Phase II Clinical Development Program (S42.009)
DP  - 2014 Apr 08
TA  - Neurology
PG  - S42.009
VI  - 82
IP  - 10 Supplement
4099  - http://n.neurology.org/content/82/10_Supplement/S42.009.short
4100  - http://n.neurology.org/content/82/10_Supplement/S42.009.full
SO  - Neurology2014 Apr 08; 82
AB  - Objective: To provide an overview of a Phase II clinical development program initiated by Forest Research Institute, designed to provide an initial assessment of the efficacy, safety, and tolerability of memantine in children (6-12 years of age) with autism spectrum disorder (ASD). Background: ASD may involve abnormally high levels of the neurotransmitter glutamate. Memantine, an antagonist of N-methyl-D-aspartate glutamate receptors, is approved for patients with moderate to severe Alzheimer’s disease (AD), in whom it was shown to provide communication benefits. Memantine-associated benefits in communication and social behavior also have been observed in open-label autism trials. Methods: Brief description of the Phase II program studies. Results: A Phase II, 14-week, randomized, placebo-controlled trial (MEM-MD-57A, NCT00872898; N=121) assessed optimal dosing, efficacy, and safety of memantine in children with autism. The primary efficacy parameter was the change from baseline in the Social Responsiveness Scale (SRS) total raw score. MEM-MD-57A completers were eligible to enter a 48-week, open-label extension (MEM-MD-67, N=102). In a separate study, children with ASD receiving memantine for 蠅12 weeks within a 50-week, open-label, safety study (MEM-MD-91, NCT01592786; N=906) who showed an SRS response (improvement 蠅10 points) on 2 consecutive visits separated by at least 2 weeks were transitioned into a 12-week, placebo-controlled, randomized-withdrawal study (MEM-MD-68, NCT01592747; N=479), whose primary efficacy parameter was the proportion of patients with loss of therapeutic response. Finally, a 48-week, open-label trial (MEM-MD-69; NCT01592773; N=748) assessed the long-term efficacy and safety of memantine in children who have completed studies MEM-MD-67, MEM-MD-68, or MEM-MD-91, or who discontinued study MEM-MD-68 due to loss of therapeutic response. Conclusions: This report provides an overview of the initial program to assess memantine for the treatment of ASD, and includes data from the first studies. More information can be found at ClinicalTrials.gov. Studies supported by: Forest Laboratories, Inc.Disclosure: Dr. Katz has received personal compensation for activities with Forest Laboratories, Inc. as an employee. Dr. Lateiner has received personal compensation for activities with Forest Laboratories, Inc. as an employee. Dr. Spera has received personal compensation for activities with Forest Laboratories, Inc as an employee. Dr. Palmer has received personal compensation for activities with Forest Laboratories, Inc. as an employee. Dr. Graham has received personal compensation for activities with Forest Laboratories Inc., as an employee.Wednesday, April 30 2014, 4:00 pm-5:45 pm