A Trial of CM-AT in Children With Autism

A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881452

Acronym

CM-AT

Enrollment

182

Registered

2009-04-15

Start date

2009-05-31

Completion date

2011-09-30

Last updated

2018-04-19

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 safe and effective in treating the core symptoms of autism.

Detailed description

Autism is currently a significant cause of disability in the pediatric population. Treatment 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.

Interventions

DRUGCM-AT

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

DRUGPlacebo

Single unit dose powder of non-active substance administered 3 times per day for 90 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 8 Years

Healthy volunteers

Inclusion criteria

* Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)

Exclusion criteria

* Patient weighing \< 11kg (24.2 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) * 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.

Design outcomes

Primary

Measure	Time frame
Evidence of changes in behavior scales associated with the core symptoms of autism	Baseline, 14 days, 30 days, 60 days, 90 days

Secondary

Measure	Time frame
Other key measures of behavior and quality of life associated with autism	Baseline, 14 days, 30 days, 60 days, 90 days

Countries

United States

Outcome results

None listed

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