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

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.