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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Merz Pharmaceuticals GmbH
• Treatments: Memantine

Criteria

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