A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)

• Status: Completed
• Trial end date: 2017-12-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Curemark

Criteria

Inclusion Criteria:

• Meets the current Diagnostic and Statistical Manual with Mental Disorders (DSM-IV-TR) for Autism (Autistic Disorder), screened by SCQ and confirmed by ADI-R;

Exclusion Criteria:

• Patient weighing < 13kg (28.6 lbs)

• Previous allergy to porcine (pork) products

• Previous history of severe head trauma or stroke, loss of consciousness, seizure (or need for seizure medication either present or past) within one year of entering study or uncontrolled systemic disease

• Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease, muscular dystrophy, known genetic disorder, blood dyscrasia, ongoing GI disease

• Evidence of severe, moderate or uncontrolled systemic disease; and/or any co-morbid condition which in the Investigator's or Medical Director's opinion makes it undesirable for the subject to participate in the study or jeopardizes compliance with the protocol;

• Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion);

• Ongoing dietary restriction for allergy or other reasons except nut allergies (lactose-free allowable);

• Use of of any stimulant medication must be discontinued 5 days prior to entering the study.

• Subject must have a stable dose of SSRI's for at least 30 days.

• Inability to ingest study drug and/or follow prescribed dosing schedule