Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism

Not Recruiting

Trial ID: NCT00872898


The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

Official Title

An Open-label (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism

Stanford Investigator(s)

Antonio Hardan, M.D.
Antonio Hardan, M.D.

Professor of Psychiatry and Behavioral Sciences


Inclusion Criteria:

   - Males or females ages 6 to 12 years

   - Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic
   Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 & 3).

   - A knowledgeable caregiver capable of providing reliable information about the
   patient's condition, able to attend all clinic visits with the patient

   - Patients over age 12, only if they completed Study MEM-PK-21

Exclusion Criteria:

   - Medical history of active epilepsy/seizure disorder except simple febrile seizures

   - Participation in any other clinical investigation using an experimental drug within 30
   days of the start of this study


drug: Placebo

drug: Memantine - Extended Release (ER)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Robin Libove