MEM-MD-91: Open Label Study of Memantine in Pediatric Patients

• Research type

  Research Study

• Full title

  An Open-Label Study of the Safety and Tolerability Of Memantine In Pediatric Patients With Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

• IRAS ID

  107657

• Contact name

  Paul Gringras

• Sponsor organisation

  Forest Research Institute, Inc.

• Eudract number

  2012-001616-33

• Clinicaltrials.gov Identifier

  NCT01592786

• Research summary

  This international phase 2, open-label study aims to evaluate the safety and tolerability of memantine in paediatric patients with autism, Asperger??s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in the follow-up randomised withdrawal 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 192 patients aged 6-12 years will take part in this study and will be in the study for up to 50 weeks.

• REC name

  Wales REC 3

• REC reference

  12/WA/0201

• Date of REC Opinion

  14 Nov 2012

• REC opinion

  Further Information Favourable Opinion