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:Any
Updated:9/23/2012
Start Date:September 2012
End Date:August 2014
Contact:Sandra Beaird
Email:info@forestpharm.com
Phone:1-800-678-1605

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An Open-Label Extension 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 objective of this study is to evaluate the long-term safety and tolerability of
memantine in the treatment of pediatric patients with autism, Asperger's Disorder or
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).


This clinical study will be a 48-week, multicenter, open-label extension study in pediatric
outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at approximately 180
study centers. Patients may be eligible for this long-term extension study if they have:

- completed the open-label Study MEM MD 67,

- completed the open-label Study MEM-MD-91,

- completed the double-blind study MEM-MD-68,

- discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response

Inclusion Criteria:

- Patients who completed Study MEM-MD-67, MEM-MD-68 or MEM-MD-91.

- Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss of
therapeutic response.

Exclusion Criteria:

- Patients who discontinued a preceding memantine study due to an adverse event
possibly related to study drug
We found this trial at
87
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Seattle, Washington 98121
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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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Avon Lake, Ohio 44012
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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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Brandon, Florida 33511
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Bronx, New York 10467
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Cambridge, Massachusetts 02138
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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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Cleveland, Ohio 44109
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Cleveland, Ohio 44106
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Clinton, Utah 84015
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Columbus, Ohio 43210
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Destin, Florida 32541
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Dothan, Alabama 36303
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Evansville, Indiana 47713
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Fargo, North Dakota 58103
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Fort Wayne, Indiana 46805
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Gainesville, Florida 32607
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Glendale, California 91206
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Gresham, Oregon 97030
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Gulf Breeze, Florida 32561
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Hartford, Connecticut 06106
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Henderson, Nevada 89052
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Hialeah, Florida 33012
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Houston, Texas 77021
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Houston, Texas 77054
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Imperial, California 92251
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Indianapolis, Indiana 46260
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Indianapolis, Indiana 46202
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Jacksonville, Florida 32216
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Lake Charles, Louisiana 70605
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Las Vegas, Nevada 89128
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Lexington, Massachusetts 02421
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Lincoln, Nebraska 68526
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Lincoln, Nebraska 68516
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Little Rock, Arkansas 72202
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Los Angeles, California 90024
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Louisville, Kentucky 40202
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Maitland, Florida 32751
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McMurray, Pennsylvania 15317
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Media, Pennsylvania 19063
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Memphis, Tennessee 38119
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Miami, Florida 33155
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Miami, Florida 33175
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Miami, Florida 33133
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Middleton, Wisconsin 53562
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Milwaukee, Wisconsin 53201
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Naperville, Illinois 60563
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Nashville, Tennessee 37232
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Neptune, New Jersey 07753
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New Orleans, Louisiana 70112
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Newton, Massachusetts 02459
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Norfolk, Virginia 23507
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Oakland Park, Florida 33334
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Oceanside, California 92056
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Orlando, Florida 32803
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Owensboro, Kentucky 42301
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Phoenix, Arizona 85006
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Portland, Oregon 97239
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Roanoke, Virginia 24014
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Rockledge, Florida 32955
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Rockville, Maryland 20852
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Salt Lake City, Utah 84106
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San Francisco, California 94143
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Santa Ana, California 92701
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Santa Ana, California 92705
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Sherman Oaks, California 91403
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Sioux Falls, South Dakota 57105
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Springfield, Massachusetts 01199
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Toms River, New Jersey 08755
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Tucson, Arizona 85718
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Tulsa, Oklahoma 74104
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Washington, District of Columbia 20010
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Wellington, Florida 33414
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Wichita, Kansas 67214
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