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

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.

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.