Completed

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

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What is being tested

CM-AT

+ Placebo

Drug
Who is being recruted

Autism Spectrum Disorder+2

+ Autistic Disorder

+ Mental Disorders

From 3 to 8 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: May 2009
See protocol details

Summary

Principal SponsorCuremark
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism
NCT00881452
Principal SponsorCuremark
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

182 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 8 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autism Spectrum DisorderAutistic DisorderMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)

Group II

Placebo
Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

Southwest Autism Research and Resource Center

Phoenix, United StatesOpen Southwest Autism Research and Resource Center in Google Maps
Suspended

University of California, Davis, M.I.N.D. Institute

Sacramento, United States
Suspended

University of California, San Francisco

San Francisco, United States
Suspended

Neuropsychiatric Research Center of Orange County

Santa Ana, United States
Completed19 Study Centers