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A Trial of CM-AT in Children With Autism- Open Label Extension Study - NCT00912691-32763(Clinical Trial 365585)



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City:  Orange City
State:  
FL
Zip Code: 32763
Conditions: Autism
Purpose: The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.
Study summary: Autism is currently a significant cause of disability in the pediatric population. CM-AT 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. It is formulated to be released in the small intestine to enhance protein digestion thus increasing the availability of essential amino acids.
Criteria: Inclusion Criteria: - Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD) - Completed 00101 Protocol 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) - Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance
Study is available at: Lake Mary Pediatrics
Orange City, FL 32763
United States

Primary Contact:
Heidi Andersen, RN
Phone: 386-960-8282
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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