A Trial of CM-AT in Children With Autism- Open Label Extension Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether CM-AT is 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. CM-AT 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. It is formulated to be released in the small intestine to enhance protein digestion thus increasing the availability of essential amino acids.

Official Title
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A Phase III Open Label Extension Study of CM-AT in Children With Autism

Conditions
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Autism

Intervention / Treatment
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* Drug: CM-AT


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) Ongoing 00102 Protocol required completion of 00101 Protocol Now recruiting subjects directly into 00102 Protocol Exclusion Criteria: Ongoing study required patients to be 3-8 years old weighing < 11kg (24.2 lbs.), and achieving ages 9-12 years old weighing < 22kg (48.4 lbs.). Newly recruited subjects must be between ages 9 - 12 years old weighing < 22kgs (48.4 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) Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CM-AT | Drug: CM-AT<br>* Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days<br>|

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, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other key measures of behavior and quality of life associated with autism |  | Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks | 

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