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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Curemark

Criteria

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