A Trial of CM-AT in Children With Autism

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Curemark
• Treatments: Citric Acid

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.