Trial | NCT00881452  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cm-at ...

  • Study Participants

    182
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.
Study Started
May 31
2009
Primary Completion
Jun 30
2011
Study Completion
Sep 30
2011
Last Update
Apr 19
2018

Drug CM-AT

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

Drug Placebo

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)

CM-AT Active Comparator

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

Placebo Placebo Comparator

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

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.
No Results Posted