An Open Label Study of CM-AT for the Treatment of Children With Autism

Inclusion Criteria: * Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in Sponsor 00103 Study * Completion of the Sponsor's 00103 Study who continue to meet eligibility requirements * Currently in the 00102 open label study and continue to meet eligibility requirements * Subjects who initially qualified for 00103 screening, who subsequently failed Baseline entrance criteria for randomization (@Visit 1) Baseline assessment of the ABC eligibility requirement who continue to meet eligibility requirements * Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R Exclusion Criteria: * Patient weighing \< 13kg * Allergy to porcine products * Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase * History of severe head trauma, as defined by loss of consciousness or hospitalization, skull fracture or stroke. * Seizure within the last year prior to enrollment, or the need for seizure medications either at present or in the past. * Evidence or history of severe, moderate or uncontrolled systemic disease * Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose free is allowable but not dairy free. * Inability to ingest the study drug / non-compliance with dosing schedule. * Inability to follow the prescribed dosing schedule. * Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to the initial randomized study period. * Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days prior to entering the study. * History of premature birth \<35 weeks gestation. * Prior history of stroke in utero or other in utero insult.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.