Overview

This trial is active, not recruiting.

Condition autism
Treatment cm-at
Phase phase 3
Sponsor Curemark
Start date January 2010
End date August 2016
Trial size 170 participants
Trial identifier NCT00912691, 00102/Autism

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
CM-AT
cm-at
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

Primary Outcomes

Measure
Evidence of changes in behavior scales associated with the core symptoms of autism
time frame: Baseline, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks

Secondary Outcomes

Measure
Other key measures of behavior and quality of life associated with autism
time frame: Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks

Eligibility Criteria

Male or female participants from 9 years up to 12 years old.

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

Additional Information

Official title A Phase III Open Label Extension Study of CM-AT in Children With Autism
Principal investigator Eugene Arnold, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Curemark.