Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
| Status: | Archived |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2009 |
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
The purpose of this study is to investigate the safety and efficacy of memantine HCl, as
well as its extent of absorption in pediatric patients with autism.
This is a multicenter, two-part study in pediatric (ages 6 to 12 years) patients diagnosed
with autism.
Patients participating In Part One will receive a single open-label dose of memantine HCl.
Blood samples for pharmacokinetic analysis will be collected.
Part Two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study
evaluating change in all core domains (social interactions, communication, and restricted
interests and repetitive behaviors) of autism.
We found this trial at
12
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials