A Trial of CM-AT in Children With Autism

Curemark

Status and phase: Completed; Phase 3

Conditions: Autism

Treatments: Drug: Placebo; Drug: CM-AT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881452

00101

Details and patient eligibility

About

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

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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182 participants in 2 patient groups, including a placebo group

CM-AT

Active Comparator group

Description:

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

Treatment:

Drug: CM-AT

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo