A Trial of CM-AT in Children With Autism

Completed · Phase 3 · Has a placebo group

Conditions studied: Autism

In brief

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

Key facts

Study ID

NCT00881452

Run by

Curemark

People needed

182

Starts

2009-05-01

Expected to finish

2011-09-01

Last updated by the study team

2018-04-19

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)

You may not qualify if…

• 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.

Where it is running

• 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 Health Science Center — Shreveport, Louisiana, United States
• Saint Peters University Hospital — New Brunswick, New Jersey, 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
• Cyn3rgy Research — Gresham, Oregon, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas, Houston — Houston, Texas, United States
• Westside Medical — Clinton, Utah, United States

Full record on ClinicalTrials.gov

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