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

Completed · Phase 3

Conditions studied: Autism

In brief

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

Key facts

Study ID

NCT00912691

Run by

Curemark

People needed

165

Starts

2010-01-01

Expected to finish

2016-02-01

Last updated by the study team

2019-03-01

Who can join

Age: 9 and older, up to 12. 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)
• Ongoing 00102 Protocol required completion of 00101 Protocol
• Now recruiting subjects directly into 00102 Protocol

You may not qualify if…

• 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

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 — 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
• University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Oklahoma State University, Child Study Center — Oklahoma City, Oklahoma, United States
• Cyn3rgy Research Center — Gresham, Oregon, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• Universtiy of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas, Houston — Houston, Texas, United States
• Ericksen Research & Development — Clinton, Utah, United States

Full record on ClinicalTrials.gov

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