This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.
Autism is clearly a significant cause of disability in the pediatric population. Treatment is based on the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
405
Single unit does powder of active substance (CM-AT) administered 3 times per day
Aberrant Behavioral Checklist: Subscale of Irritability / Agitation (ABC-I) at fecal chymotrypsin (FCT) levels less than or equal to 12.6
Time frame: Change from Baseline to each post-baseline visit, through study completion Week 72.
Aberrant Behavior Checklist: Subscale of Lethargy / Social Withdrawal (ABC-L) at fecal chymotrypsin (FCT) levels less than or equal to 12.6
Time frame: Change from Baseline to each post-baseline visit, through study completion Week 72.
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Southwest Autism Research & Resource Center (S.A.R.R.C.)
Phoenix, Arizona, United States
University of Arizona, Pediatrics Multidisciplinary Research Unit
Tucson, Arizona, United States
Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)
Little Rock, Arkansas, United States
N.R.C. Research Institute
Orange, California, United States
M.I.N.D. Institute (Univ.of California, Davis)
Sacramento, California, United States
University of California (U.C.S.F.)
San Francisco, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Yale Child Study Center
New Haven, Connecticut, United States
Segal Institute For Clinical Research
North Miami, Florida, United States
Advent Health -Lake Mary Pediatrics
Orange City, Florida, United States
...and 21 more locations