A Trial of CM-AT in Children With Autism- Open Label Extension Study - NCT00912691-32763 (Clinical Trial 365585)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy365585.aspx
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| City: |
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Orange City |
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State:
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FL |
| Zip Code: |
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32763 |
| Conditions: |
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Autism |
| Purpose: |
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The purpose of this study is to determine whether CM-AT is effective in treating the core
symptoms of autism.
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| Study summary: |
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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: |
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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 |
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| Study is available at: |
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Lake Mary Pediatrics
Orange City, FL 32763
United States
Primary Contact:
Heidi Andersen, RN
Phone: 386-960-8282 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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