A Trial of CM-AT in Children With Autism



Status:Completed
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:3 - 8
Updated:4/21/2018
Start Date:May 2009
End Date:September 2011

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A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism

The purpose of this study is to determine whether CM-AT is safe and effective in treating the
core symptoms of autism.

Autism is currently a significant cause of disability in the pediatric population. Treatment
is based upon the observation that many children with autism do not digest protein. CM-AT is
a proprietary enzyme that is designed as a powder taken three times a day.

Inclusion Criteria:

- Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR)
diagnostic criteria for autistic disorder (AD)

Exclusion Criteria:

- Patient weighing < 11kg (24.2 lbs.)

- Demonstrated previous allergy to porcine (pork) products

- Previous history of severe head trauma or stroke, seizure within one year of entering
study or uncontrolled systemic disease

- Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease

- Within 30 days of starting the study, certain supplementation, chelation or dietary
restriction (a 30 day washout period would be required for inclusion)

- Use of of any stimulant medication must be discontinued 5 days prior to entering the
study.

- Subject must have a stable dose of SSRI's for at least 30 days.
We found this trial at
19
sites
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Pittsburgh, PA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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Clinton, Utah 84015
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Clinton, UT
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Gresham, Oregon 97030
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Gresham, OR
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Hershey, Pennsylvania 17033
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Hershey, PA
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Hoffman Estates, Illinois 60169
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Houston, Texas 77030
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Houston, TX
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254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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New Brunswick, NJ
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New York, New York 10029
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New York, NY
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1100 Northeast 13th Street
Oklahoma City, Oklahoma 73117
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Oklahoma City, OK
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Orange City, Florida 32763
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Orange City, FL
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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Phoenix, AZ
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Sacramento, CA
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San Francisco, California 94143
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Santa Ana, CA
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Shreveport, LA
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Smyrna, Georgia 30080
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Smyrna, GA
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