A Trial of CM-AT in Children With Autism- Open Label Extension Study

Curemark

Status and phase

Completed

Phase 3

Conditions

Autism

Treatments

Drug: CM-AT

Study type

Interventional

Funder types

Industry

Identifiers

NCT00912691

00102/Autism

Details and patient eligibility

About

The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.

Full description

Autism is currently a significant cause of disability in the pediatric population. CM-AT is based upon the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a powder taken three times a day. It is formulated to be released in the small intestine to enhance protein digestion thus increasing the availability of essential amino acids.

Enrollment

165 patients

Sex

All

Ages

9 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)
Ongoing 00102 Protocol required completion of 00101 Protocol
Now recruiting subjects directly into 00102 Protocol

Exclusion criteria

Ongoing study required patients to be 3-8 years old weighing < 11kg (24.2 lbs.), and achieving ages 9-12 years old weighing < 22kg (48.4 lbs.).
Newly recruited subjects must be between ages 9 - 12 years old weighing < 22kgs (48.4 lbs.)
Demonstrated previous allergy to porcine (pork) products
Previous history of severe head trauma or stroke, seizure within one year of entering study or uncontrolled systemic disease
Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease
Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion)
Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance