A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)

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 in children with all levels of fecal chymotrypsin.

Key facts

Study ID

NCT02410902

Run by

Curemark

People needed

190

Starts

2015-05-13

Expected to finish

2017-12-22

Last updated by the study team

2023-05-24

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Meets the current Diagnostic and Statistical Manual with Mental Disorders (DSM-IV-TR) for Autism (Autistic Disorder), screened by SCQ and confirmed by ADI-R;

You may not qualify if…

• Patient weighing < 13kg (28.6 lbs)
• Previous allergy to porcine (pork) products
• Previous history of severe head trauma or stroke, loss of consciousness, seizure (or need for seizure medication either present or past) within one year of entering study or uncontrolled systemic disease
• Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease, muscular dystrophy, known genetic disorder, blood dyscrasia, ongoing GI disease
• Evidence of severe, moderate or uncontrolled systemic disease; and/or any co-morbid condition which in the Investigator's or Medical Director's opinion makes it undesirable for the subject to participate in the study or jeopardizes compliance with the protocol;
• Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion);
• Ongoing dietary restriction for allergy or other reasons except nut allergies (lactose-free allowable);
• 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.
• Inability to ingest study drug and/or follow prescribed dosing schedule

Where it is running

• Southwest Autism Research & Resource Center (S.A.R.R.C.) — Phoenix, Arizona, United States
• University of Arizona, Pediatrics Multidisciplinary Research Unit — Tucson, Arizona, United States
• Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.) — Little Rock, Arkansas, United States
• N.R.C. Research Institute — Orange, California, United States
• M.I.N.D. Institute (Univ.of California, Davis) — Sacramento, California, United States
• University of California (U.C.S.F.) — San Francisco, California, United States
• IMMUNOe RESEARCH CENTERS — Centennial, Colorado, United States
• Yale Child Study Center — New Haven, Connecticut, United States
• Segal Institute For Clinical Research — North Miami, Florida, United States
• Florida Hospital Medical Group-Lake Mary Pediatrics — Orange City, Florida, United States
• Kaley Kildahl — Orlando, Florida, United States
• Research Institute of Deaconess Clinic — Evansville, Indiana, United States
• Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
• L.S.U. Health Sciences Center — Shreveport, Louisiana, United States
• Detroit Clinical Research Center, P.C. — Bingham Farms, Michigan, United States
• Children'S Specialized Hospital — Egg Harbor, New Jersey, United States
• Children'S Specialized Hospital — Toms River, New Jersey, United States
• Clinical Research Center of Nj — Voorhees Township, New Jersey, United States
• Lovelace Scientific Resources — Albuquerque, New Mexico, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Montefiore Med.Center, Autism & Obsessive Compulsive Spectrum Prog. — The Bronx, New York, United States
• Duke Center For Autism and Brain Development — Durham, North Carolina, United States
• Cleveland Clinic, Center For Autism Research — Cleveland, Ohio, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• Carolina Clinical Trials, Inc. — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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