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Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
Not Recruiting
Trial ID: NCT00872898
Purpose
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.
Professor of Psychiatry and Behavioral Sciences
Eligibility
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
Intervention(s):
drug: Placebo
drug: Memantine - Extended Release (ER)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Robin Libove
6507361235