A Trial of CM-AT in Children With Autism

Study Overview
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Brief Summary
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The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.

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

Conditions
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Autism

Intervention / Treatment
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* Drug: CM-AT
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CM-AT<br>CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg) | Drug: CM-AT<br>* Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days<br>* Other names: 900mg CM-AT (pancreatic enzyme concentrate, 720mg;|
| Placebo Comparator: Placebo<br>Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w) | Drug: Placebo<br>* Single unit dose powder of non-active substance administered 3 times per day for 90 days<br>* Other names: 900mg (Sucanate (98% w/w), Citric Acid (2% w/w);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of changes in behavior scales associated with the core symptoms of autism |  | Baseline, 14 days, 30 days, 60 days, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other key measures of behavior and quality of life associated with autism |  | Baseline, 14 days, 30 days, 60 days, 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism