MEM-MD-68:A Double-Blind Study of Memantine in Pediatric Patients
Research type
Research Study
Full title
A Double-Blind, Placebo Controlled, Randomized Withdrawal Study of the Safety and Efficacy Of Memantine In Pediatric Patients With Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine
IRAS ID
107658
Contact name
Paul Gringras
Sponsor organisation
Forest Research Institute, Inc.
Eudract number
2012-001568-31
Clinicaltrials.gov Identifier
Research summary
This international phase-2, double-blind placebo-controlled randomised withdrawal study aims to evaluate the safety, tolerability and efficacy of memantine therapy compared with placebo in paediatric patients with autism, Asperger??s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) previously treated with memantine in the MEM-MD-91 study.Autism, Asperger??s Disorder, and PDD-NOS are classifications of autistic spectrum disorder (ASD) within the pervasive developmental disorders (PDD). All three of these disorders are characterised by impairments in social interactions but have varied degrees of other symptoms. Memantine is a moderate-affinity, uncompetitive NMDA receptor antagonist. Studies have suggested clinical improvement in social interactions and communication and a beneficial effect in children with ASD and autism treated with memantine. There are currently no medications specifically approved for the treatment of any of the core domains of autism. Results from studies support the hypothesis that memantine is a valid therapeutic candidate to treat the core symptoms of autism and could also potentially benefit patients with Asperger??s Disorder and PDD-NOS. Approximately 96 patients aged 6-12 years will take part in this study and will be in the study for up to 12 weeks.
REC name
Wales REC 3
REC reference
12/WA/0202
Date of REC Opinion
14 Nov 2012
REC opinion
Further Information Favourable Opinion