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Completed

NCT Number: NCT00881452

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southwest Autism Research and Resource Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM-AT

Drug

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

Other names: 900mg CM-AT (pancreatic enzyme concentrate, 720mg

Placebo

Drug

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

Other names: 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)

Primary outcomes

  1. 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 outcomes

  1. Other key measures of behavior and quality of life associated with autism

    Time frame: Baseline, 14 days, 30 days, 60 days, 90 days

Sponsors and collaborators

Lead sponsor

Curemark

Industry

Registry information

Official study title

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

Acronym: CM-AT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2009
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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