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

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism

In brief

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.

Key facts

Study ID

NCT00872898

Run by

Forest Laboratories

People needed

124

Starts

2009-04-01

Last updated by the study team

2014-01-14

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site — Phoenix, Arizona, United States
• Forest Investigative Site — Sacramento, California, United States
• Forest Investigative Site — San Francisco, California, United States
• Forest Investigative Site — Santa Ana, California, United States
• Forest Investigative Site — Stanford, California, United States
• Forest Investigative Site — Jacksonville Beach, Florida, United States
• Forest Investigative Site — St. Petersburg, Florida, United States
• Forest Investigative Site — Hoffman Estates, Illinois, United States
• Forest Investigative site — Naperville, Illinois, United States
• Forest Investigative Site — Indianapolis, Indiana, United States
• Forest Investigative Site — Cambridge, Massachusetts, United States
• Forest Investigative Site — Toms River, New Jersey, United States
• Forest Investigative Site — Voorhees Township, New Jersey, United States
• Forest Investigative Site — Manhasset, New York, United States
• Forest Investigative Site — Cleveland, Ohio, United States
• Forest Investigative Site — Columbus, Ohio, United States
• Forest Investigative Site — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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