Status:
COMPLETED
A Trial of CM-AT in Children With Autism- Open Label Extension Study
Lead Sponsor:
Curemark
Conditions:
Autism
Eligibility:
All Genders
9-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.
Detailed Description
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 enzy...
Eligibility Criteria
Inclusion
- Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)
- Ongoing 00102 Protocol required completion of 00101 Protocol
- Now recruiting subjects directly into 00102 Protocol
Exclusion
- Ongoing study required patients to be 3-8 years old weighing \< 11kg (24.2 lbs.), and achieving ages 9-12 years old weighing \< 22kg (48.4 lbs.).
- Newly recruited subjects must be between ages 9 - 12 years old weighing \< 22kgs (48.4 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00912691
Start Date
January 1 2010
End Date
February 1 2016
Last Update
March 1 2019
Active Locations (19)
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1
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
2
University of California, Davis, M.I.N.D. Institute
Sacramento, California, United States, 95817
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States, 92701