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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.
 
ClinicalTrials.gov Identifier: NCT02410902
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Curemark

Tracking Information
First Submitted Date  ICMJE March 19, 2015
First Posted Date  ICMJE April 8, 2015
Last Update Posted Date December 27, 2018
Study Start Date  ICMJE May 2015
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02410902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
Official Title  ICMJE A Double Blind, Randomized, Placebo-Controlled Study of CM-AT for the Treatment of Autism in Children With All Levels of Fecal Chymotrypsin (FCT)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • Drug: CM-AT
    Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
  • Drug: PLACEBO
    Single unit dose powder of non-active substance administered 3 times per day for 90 days
    Other Name: placebo powder
Study Arms  ICMJE
  • Experimental: CM-AT
    Active substance in single unit dose powder
    Intervention: Drug: CM-AT
  • Placebo Comparator: Placebo
    Placebo powder of inactive substance
    Intervention: Drug: PLACEBO
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2018)
335
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2015)
300
Actual Study Completion Date  ICMJE December 22, 2017
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02410902
Other Study ID Numbers  ICMJE 00103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Curemark
Study Sponsor  ICMJE Curemark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah Pearson, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Robert Hendren, DO University of California, San Francisco
PRS Account Curemark
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP