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

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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
Boca Raton, Florida 33432
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Boca Raton, FL
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Baltimore, Maryland 21285
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Baltimore, MD
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Chicago, Illinois 60608
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Chicago, IL
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Cleveland, Ohio 44106
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Cleveland, OH
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Enid, Oklahoma 73707
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Enid, OK
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Lincoln, Nebraska 68506
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Lincoln, NE
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Manhasset, New York 11030
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Manhasset, NY
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Oklahoma City, Oklahoma 73116
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Oklahoma City, OK
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Pittsburgh, PA
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Pittsburgh, Pennsylvania 15203
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Sacramento, California 95817
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Sacramento, CA
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San Francisco, California 94143
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San Francisco, CA
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