Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
Trial ID or NCT#
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.
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
- - 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
- - 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
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