A 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.

Full Title of Study: “A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2011

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.


  • 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

Arms, Groups and Cohorts

  • Active Comparator: CM-AT
    • CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)
  • Placebo Comparator: Placebo
    • Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Other key measures of behavior and quality of life associated with autism
    • Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Curemark
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eugene Arnold, MD MEd., Principal Investigator, Nisonger Center Ohio State University


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