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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02410902
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : December 27, 2018
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Drug: CM-AT Drug: PLACEBO Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Placebo-Controlled Study of CM-AT for the Treatment of Autism in Children With All Levels of Fecal Chymotrypsin (FCT)
Study Start Date : May 2015
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Arm Intervention/treatment
Experimental: CM-AT
Active substance in single unit dose powder
Drug: CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

Placebo Comparator: Placebo
Placebo powder of inactive substance
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Other Name: placebo powder

Primary Outcome Measures :
  1. Primary outcome measurements to determine efficacy of treatment with CM-AT versus placebo for changes in the Aberrant Behavior Checklist subscale for Irritability / Agitation (ABC-I) between baseline and Week 12/Termination visit [ Time Frame: Screening, baseline/14 days, 28 days, 42 days, 56 days, 70 days, 84 days, 98 days ]

Secondary Outcome Measures :
  1. Secondary Outcome measurements of changes in the Aberrant Behavior Checklist Checklist subscale for Lethargy / Social Withdrawal (ABC-L) between baseline and Week 12/Termination visit [ Time Frame: Screening, baseline/14 days, 28 days, 42 days, 56 days, 70 days, 84 days, 98 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02410902

  Hide Study Locations
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United States, Arizona
Southwest Autism Research & Resource Center (S.A.R.R.C.)
Phoenix, Arizona, United States, 85006
University of Arizona, Pediatrics Multidisciplinary Research Unit
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)
Little Rock, Arkansas, United States, 72202
United States, California
N.R.C. Research Institute
Orange, California, United States, 92868
M.I.N.D. Institute (Univ.of California, Davis)
Sacramento, California, United States, 95817
University of California (U.C.S.F.)
San Francisco, California, United States, 94143-0984
United States, Colorado
Centennial, Colorado, United States, 80112
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06519
United States, Florida
Segal Institute For Clinical Research
North Miami, Florida, United States, 33161
Florida Hospital Medical Group-Lake Mary Pediatrics
Orange City, Florida, United States, 32763
Kaley Kildahl
Orlando, Florida, United States, 32803
United States, Indiana
Research Institute of Deaconess Clinic
Evansville, Indiana, United States, 47713
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
L.S.U. Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Michigan
Detroit Clinical Research Center, P.C.
Bingham Farms, Michigan, United States, 48025
United States, New Jersey
Children'S Specialized Hospital
Egg Harbor Township, New Jersey, United States, 08234
Children'S Specialized Hospital
Toms River, New Jersey, United States, 08755
Clinical Research Center of Nj
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Montefiore Med.Center, Autism & Obsessive Compulsive Spectrum Prog.
Bronx, New York, United States, 10467
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, North Carolina
Duke Center For Autism and Brain Development
Durham, North Carolina, United States, 27705
United States, Ohio
Cleveland Clinic, Center For Autism Research
Cleveland, Ohio, United States, 44104
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States, 29407
United States, Tennessee
Vanderbilt University Med.Center -Treatment & Research Inst. For Asd
Nashville, Tennessee, United States, 37232-2551
United States, Texas
University of Texas, Houston Dept. of Psychiatry and Behavioral Sciences
Houston, Texas, United States, 77054
United States, Utah
Ericksen Research & Development
Clinton, Utah, United States, 84015
United States, Virginia
University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences
Charlottesville, Virginia, United States, 22903
Neuroscience, Inc.
Herndon, Virginia, United States, 20170
Carilion Clinic-Virginia Tech, Carilion School of Medicine
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
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Principal Investigator: Deborah Pearson, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Robert Hendren, DO University of California, San Francisco

Baio, J. Prevalence of Autism Spectrum Disorders — Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States. (2008), Retrieved from

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Responsible Party: Curemark Identifier: NCT02410902     History of Changes
Other Study ID Numbers: 00103
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Keywords provided by Curemark:
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders