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

Phase 3

Completed

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

• Registration Number: NCT00912691
• Lead Sponsor: Curemark

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Study Start: 2010-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2019-02
• Disposition First Submitted: 2019-02-26
• Disposition First Submitted QC: 2019-02-26
• Last Update Submitted: 2019-02-26
• Disposition First Posted: 2019-03-01
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CM-AT	CM-AT

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (19)

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

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

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

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

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

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

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

Louisiana State University; 🇺🇸 Shreveport, Louisiana, United States

Saint Peter's University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

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

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