A Trial of CM-AT in Children With Autism- Open Label Extension Study
- Registration Number
- NCT00912691
- Lead Sponsor
- Curemark
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 CM-AT CM-AT
- Primary Outcome Measures
Name Time Method Evidence of changes in behavior scales associated with the core symptoms of autism Baseline, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks
- Secondary Outcome Measures
Name Time Method Other key measures of behavior and quality of life associated with autism Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks
Trial Locations
- Locations (19)
Universtiy of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of California, Davis, M.I.N.D. Institute
🇺🇸Sacramento, California, United States
Southwest Autism Research and Resource Center
🇺🇸Phoenix, Arizona, United States
Lake Mary Pediatrics
🇺🇸Orange City, Florida, United States
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Institute for Behavioral Medicine
🇺🇸Smyrna, Georgia, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Santa Ana, California, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Mount Sinai School of Medicine
🇺🇸Manhattan, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Cyn3rgy Research Center
🇺🇸Gresham, Oregon, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Ericksen Research & Development
🇺🇸Clinton, Utah, United States
Louisiana State University
🇺🇸Shreveport, Louisiana, United States
Oklahoma State University, Child Study Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Texas, Houston
🇺🇸Houston, Texas, United States