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 |
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.
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.
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
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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