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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00912691

Acronym

CM-AT

Enrollment

165

Registered

2009-06-03

Start date

2010-01-31

Completion date

2016-02-29

Last updated

2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

Autism

Brief summary

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

Detailed 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.

Interventions

DRUGCM-AT

Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame
Evidence of changes in behavior scales associated with the core symptoms of autism	Baseline, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks

Secondary

Measure	Time frame
Other key measures of behavior and quality of life associated with autism	Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026