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



Status:Completed
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:3 - 8
Updated:4/17/2018
Start Date:May 2015
End Date:December 22, 2017

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A Double Blind, Randomized, Placebo-Controlled Study of CM-AT for the Treatment of Autism in Children With All Levels of Fecal Chymotrypsin (FCT)

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.

Autism is clearly a significant cause of disability in the pediatric population. Many
children with Autism exhibit impaired protein digestion which may or may not manifest in
self-restricted diets. The inability to digest protein affects the availability of essential
amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially
restoring the pool of essential amino acids. Essential amino acids play a critical role in
the expression of several genes important to neurological function and serve as precursors to
key neurotransmitters such as serotonin and dopamine. CM-AT is a proprietary enzyme that is
designed as a granulated powder taken three times daily.

Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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
We found this trial at
32
sites
Orange, California 92868
Principal Investigator: Tony Ortiz, PhD
Phone: 714-289-1100
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
Principal Investigator: Richard Ohnmacht, MD
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Albuquerque, New Mexico 87108
Principal Investigator: Jeffrey Lewine, PhD
Phone: 505-348-9371
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Bingham Farms, Michigan 48334
Principal Investigator: Edward Dabrowski, MD
Phone: 248-716-7009
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Bronx, NY
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Centennial, Colorado 80112
Principal Investigator: Isaac Melamed, MD
Phone: 303-771-9000
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Centennial, CO
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Charleston, South Carolina 29405
Principal Investigator: Steven G. Lopez, MD
Phone: 843-576-6750
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Charlottesville, Virginia 22903
Principal Investigator: Vishal Madden, MD, MBBS
Phone: 434-243-3678
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Cleveland, Ohio 44104
Principal Investigator: Sumit Parikh, MD
Phone: 216-448-6682
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Clinton, Utah 84015
Principal Investigator: Samantha Bostrom, MD
Phone: 801-614-5522
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Durham, North Carolina 27705
Principal Investigator: Lin Sikich, MD
Phone: 888-691-1062
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6106 East Black Horse Pike
Egg Harbor Township, New Jersey 08234
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Evansville, Indiana 47713
Principal Investigator: R. Michelle Galen, MD
Phone: 812-490-4505
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Herndon, Virginia 20170
Principal Investigator: Keith Saylor, PhD, ScM
Phone: 703-787-9090
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Houston, Texas 77054
Principal Investigator: Deborah Pearson, PhD
Phone: 713-486-2591
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Lake Charles, Louisiana 70601
Principal Investigator: Kashinath G. Yadalam, MD
Phone: 337-564-6405
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Little Rock, AR
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Nashville, Tennessee 37232
Principal Investigator: Allyson B Cundiff, MD
Phone: 615-936-3288
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New Haven, Connecticut 06520
Principal Investigator: Roger J Jou, MD, MPH, PhD
Phone: 203-927-3970
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North Miami, Florida 33161
Principal Investigator: Scott Segal, MD
Phone: 305-722-8444
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2505 Junior Street
Orange City, Florida 32763
Principal Investigator: Miles Landis, MD
Phone: 386-960-8282
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Orlando, Florida 32803
Principal Investigator: Morteza Nadjafi, MD
Phone: 407-423-7149
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Phoenix, Arizona
Principal Investigator: Raun Melmed, MD
Phone: 602-218-8225
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Roanoke, Virginia 24014
Principal Investigator: Anita Kablinger, MD
Phone: 540-981-8829
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Sacramento, California 95817
Principal Investigator: Randi Hagerman, MD
Phone: 916-703-0247
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San Francisco, California 94131
Principal Investigator: Robert Hendren, DO
Phone: 415-476-7803
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Shreveport, Louisiana
Principal Investigator: Rita Horton, MD
Phone: 318-813-2070
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Staten Island, New York 10312
Principal Investigator: Mark DiBuono, MD
Phone: 347-609-0931
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2142 North Cove Boulevard
Toledo, Ohio 43606
Principal Investigator: Jeffrey Blumer, MD
Phone: 419-291-2757
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Toms River, New Jersey 08755
Principal Investigator: Yvette Janvier, MD
Phone: 732-914-1100
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Tucson, Arizona 85724
Principal Investigator: Sydney Rice, MD, MSc
Phone: 520-626-1994
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Voorhees, New Jersey 08043
Principal Investigator: Mark Mintz, MD
Phone: 856-784-1899
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