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

Autism Clinical Trial

— CM-AT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912691
• Other study ID #: 00102/Autism
• Status: Completed
• Phase: Phase 3
• Start date: January 2010
• Est. completion date: February 2016

Study information

• Verified date: February 2019
• Source: Curemark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Drug:
• CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Ericksen Research & Development	Clinton	Utah
United States	Ohio State University	Columbus	Ohio
United States	Cyn3rgy Research Center	Gresham	Oregon
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	University of Texas, Houston	Houston	Texas
United States	Mount Sinai School of Medicine	Manhattan	New York
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Oklahoma State University, Child Study Center	Oklahoma City	Oklahoma
United States	Lake Mary Pediatrics	Orange City	Florida
United States	Drexel University	Philadelphia	Pennsylvania
United States	Southwest Autism Research and Resource Center	Phoenix	Arizona
United States	Universtiy of Pittsburgh	Pittsburgh	Pennsylvania
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	Louisiana State University	Shreveport	Louisiana
United States	Institute for Behavioral Medicine	Smyrna	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Curemark

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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