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
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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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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