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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Eligibility Criteria

Ages Eligible for Study: 6 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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


Antonio Hardan, M.D.
Antonio Hardan, M.D.
Professor of Psychiatry and Behavioral Sciences

Contact us to find out if this trial is right for you.


Robin Libove