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

Curemark

Status and phase: Completed; Phase 3

Conditions: Autism

Treatments: Drug: PLACEBO; Drug: CM-AT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02410902

00103

Details and patient eligibility

About

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.

Full description

Autism is clearly a significant cause of disability in the pediatric population. Many children with Autism exhibit impaired protein digestion which may or may not manifest in self-restricted diets. The inability to digest protein affects the availability of essential amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.

Enrollment: 190 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

CM-AT

Experimental group

Description:

Active substance in single unit dose powder

Treatment:

Drug: CM-AT

Placebo

Placebo Comparator group

Description:

Placebo powder of inactive substance

Treatment:

Drug: PLACEBO