An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)



Status:Completed
Conditions:Cognitive Studies, Neurology, Neurology, Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:6 - 12
Updated:3/30/2013
Start Date:June 2012
End Date:June 2013
Contact:Sandra Beaird, Pharm.D
Email:FRXClinTrials@frx.com
Phone:1-800-678-1605

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An Open-Label Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)


The purpose of this study is to evaluate the safety and tolerability of memantine in
pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive
Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify eligible patients
for participation in the follow-up randomized withdrawal study.


This 50-week multicenter clinical study is comprised of a 2-week screening period, a 6-week
open-label dose-titration period followed by up to 42-week open-label maintenance period.

Approximately 192 pediatric patients (aged 6-12 years) may enter this study at approximately
180 study centers. Patients with at least 12 weeks of investigational product exposure who
meet the protocol specified responder criterion will be eligible to transition to a
randomized withdrawal study.

Inclusion Criteria:

1. Male or female outpatients.

2. Age of 6-12.

3. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

4. Have a family that is sufficiently organized and stable to guarantee adequate safety
monitoring and continuous attendance to clinic visits for the duration of the study

Exclusion Criteria:

1. Have enrolled in Study MEM-MD-57A

2. Medical conditions that might interfere with the conduct of the study, confound
interpretation of the study results, or endanger the patient's well-being.

3. Participation in any other clinical investigation using an experimental drug within
30 days of screening.

4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's
Disorder, and PDD-NOS.

5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise
specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder
within the past 6 months
We found this trial at
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Miami, Florida 33175
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Albuquerque, New Mexico 87108
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Albuquerque, New Mexico 87109
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Altoona, Pennsylvania 16602
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Bay City, Michigan 48706
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Bothell, Washington 98011
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Boulder, Colorado 80304
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Bradenton, Florida 32751
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Bronx, New York 10467
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Centennial, Colorado 80112
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Chapel Hill, North Carolina 27514
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Charleston, South Carolina 29407
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Charleston, West Virginia 25304
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Charlottesville, Virginia 22903
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Chicago, Illinois 60611
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Clinton, Utah 84015
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Columbus, Ohio 43210
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Detroit, Michigan 48201
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Indianapolis, Indiana 46202
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Lincoln, Nebraska 68526
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Media, Pennsylvania 19063
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Miami, Florida 33126
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Naperville, Illinois 60563
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