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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02410902
First Posted: April 8, 2015
Last Update Posted: September 7, 2017
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.
Information provided by (Responsible Party):
Curemark
  Purpose
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 Intervention Phase
Autism Drug: CM-AT Drug: PLACEBO Phase 3

Study Type: Interventional
Study Design: 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)

Further study details as provided by Curemark:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: May 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: PLACEBO
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Other Name: placebo powder

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.
  Eligibility

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02410902


  Hide Study Locations
Locations
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
IMMUNOe RESEARCH CENTERS
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
A.P.G. Research
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 City, 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
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
Montefiore Med.Center, Autism & Obsessive Compulsive Spectrum Prog.
The Bronx, New York, United States, 10467
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
Promedica Children'S Hospital - Univ. of Toledo
Toledo, Ohio, United States, 43606
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
Curemark
Investigators
Principal Investigator: Deborah Pearson, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Robert Hendren, DO University of California, San Francisco
  More Information

Publications:
Baio, J. Prevalence of Autism Spectrum Disorders — Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States. (2008), Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6103a1.htm?s_cid=ss6103a1_w.
Baio, J. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States. (2010). Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6302a1.htm?s_cid=ss6302a1_w.

Responsible Party: Curemark
ClinicalTrials.gov Identifier: NCT02410902     History of Changes
Other Study ID Numbers: 00103
First Submitted: March 19, 2015
First Posted: April 8, 2015
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Curemark:
Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders