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A Trial of CM-AT in Children With Autism (CM-AT)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 15, 2009
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
April 13, 2009
April 15, 2009
March 17, 2017
May 2009
June 2011   (Final data collection date for primary outcome measure)
Evidence of changes in behavior scales associated with the core symptoms of autism [ Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days ]
Same as current
Complete list of historical versions of study NCT00881452 on ClinicalTrials.gov Archive Site
Other key measures of behavior and quality of life associated with autism [ Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days ]
Same as current
Not Provided
Not Provided
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
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: CM-AT
    Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
  • Drug: Placebo
    Single unit dose powder of non-active substance administered 3 times per day for 90 days
  • Active Comparator: 1
    Intervention: Drug: CM-AT
  • Placebo Comparator: 2
    Placebo powder
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2011
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
3 Years to 8 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Principal Investigator: Eugene Arnold, MD MEd. Nisonger Center Ohio State University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP