Working… Menu
Trial record 1 of 2 for:    blum | Autism
Previous Study | Return to List | Next Study

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 : April 30, 2021
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.

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

Show Show 31 study locations
Sponsors and Collaborators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Curemark Identifier: NCT02410902    
Other Study ID Numbers: 00103
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: December 2018
Keywords provided by Curemark:
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders