A Trial of CM-AT in Children With Autism

Phase 3

Completed

• Conditions: Autism
• Interventions: Drug: CM-AT; Drug: Placebo

• Registration Number: NCT00881452
• Lead Sponsor: Curemark

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2009-04-13
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Study Start: 2009-05
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Disposition First Submitted: 2013-03-04
• Disposition First Submitted QC: 2013-03-11
• Disposition First Posted: 2013-03-18
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM-AT	CM-AT	CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)
Placebo	Placebo	Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)

Primary Outcome Measures

Name	Time	Method
Evidence of changes in behavior scales associated with the core symptoms of autism	Baseline, 14 days, 30 days, 60 days, 90 days

Secondary Outcome Measures

Name	Time	Method
Other key measures of behavior and quality of life associated with autism	Baseline, 14 days, 30 days, 60 days, 90 days

Trial Locations

Locations (19)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States

Lake Mary Pediatrics; 🇺🇸 Orange City, Florida, United States

Neuropsychiatric Research Center of Orange County; 🇺🇸 Santa Ana, California, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of California, Davis, M.I.N.D. Institute; 🇺🇸 Sacramento, California, United States

Southwest Autism Research and Resource Center; 🇺🇸 Phoenix, Arizona, United States

Westside Medical; 🇺🇸 Clinton, Utah, United States

Institute for Behavioral Medicine; 🇺🇸 Smyrna, Georgia, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Saint Peters University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Alexian Brothers Center for Psychiatric Research; 🇺🇸 Hoffman Estates, Illinois, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Oklahoma University Child Study Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Cyn3rgy Research; 🇺🇸 Gresham, Oregon, United States

University of Texas, Houston; 🇺🇸 Houston, Texas, United States

Louisiana State University Health Science Center; 🇺🇸 Shreveport, Louisiana, United States