Back to resultsA Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
Primary Purpose
Autism
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CM-AT
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism
Eligibility 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
Sites / Locations
- Southwest Autism Research & Resource Center (S.A.R.R.C.)
- University of Arizona, Pediatrics Multidisciplinary Research Unit
- Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)
- N.R.C. Research Institute
- M.I.N.D. Institute (Univ.of California, Davis)
- University of California (U.C.S.F.)
- IMMUNOe RESEARCH CENTERS
- Yale Child Study Center
- Segal Institute For Clinical Research
- Florida Hospital Medical Group-Lake Mary Pediatrics
- Kaley Kildahl
- Research Institute of Deaconess Clinic
- Lake Charles Clinical Trials
- L.S.U. Health Sciences Center
- Detroit Clinical Research Center, P.C.
- Children'S Specialized Hospital
- Children'S Specialized Hospital
- Clinical Research Center of Nj
- Lovelace Scientific Resources
- Montefiore Med.Center, Autism & Obsessive Compulsive Spectrum Prog.
- Richmond Behavioral Associates
- Duke Center For Autism and Brain Development
- Cleveland Clinic, Center For Autism Research
- Omega Medical Research
- Carolina Clinical Trials, Inc.
- Vanderbilt University Med.Center -Treatment & Research Inst. For Asd
- University of Texas, Houston Dept. of Psychiatry and Behavioral Sciences
- Ericksen Research & Development
- University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences
- Neuroscience, Inc.
- Carilion Clinic-Virginia Tech, Carilion School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CM-AT
Placebo
Arm Description
Active substance in single unit dose powder
Placebo powder of inactive substance
Outcomes
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
Primary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist (ABC) - Community sub scale for Irritability/Agitation (ABC-I) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-I is one of five discrete sub scales measured by the ABC. The scale range is 0-45. A higher score reflects higher severity of symptoms (irritability). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree. The score was automatically calculated by the EDC.
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
Secondary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist- Community (ABC) sub scale for Lethargy / Social Withdrawal (ABC-L) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-L is one of five discrete sub scales measured by the ABC. The scale range is 0-48. A higher score reflects higher severity of symptoms (lethargy). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02410902
Brief Title
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 13, 2015 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Curemark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CM-AT
Arm Type
Experimental
Arm Description
Active substance in single unit dose powder
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo powder of inactive substance
Intervention Type
Drug
Intervention Name(s)
CM-AT
Intervention Description
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Other Intervention Name(s)
placebo powder
Intervention Description
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Primary Outcome Measure Information:
Title
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
Description
Primary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist (ABC) - Community sub scale for Irritability/Agitation (ABC-I) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-I is one of five discrete sub scales measured by the ABC. The scale range is 0-45. A higher score reflects higher severity of symptoms (irritability). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree. The score was automatically calculated by the EDC.
Time Frame
Screening through Week 12/Termination
Secondary Outcome Measure Information:
Title
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
Description
Secondary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist- Community (ABC) sub scale for Lethargy / Social Withdrawal (ABC-L) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-L is one of five discrete sub scales measured by the ABC. The scale range is 0-48. A higher score reflects higher severity of symptoms (lethargy). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree.
Time Frame
Screening through Week 12/Termination.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Pearson, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Hendren, DO
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Autism Research & Resource Center (S.A.R.R.C.)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Arizona, Pediatrics Multidisciplinary Research Unit
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
N.R.C. Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
M.I.N.D. Institute (Univ.of California, Davis)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California (U.C.S.F.)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0984
Country
United States
Facility Name
IMMUNOe RESEARCH CENTERS
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Segal Institute For Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Florida Hospital Medical Group-Lake Mary Pediatrics
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Kaley Kildahl
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Research Institute of Deaconess Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
L.S.U. Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Detroit Clinical Research Center, P.C.
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Children'S Specialized Hospital
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Children'S Specialized Hospital
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Clinical Research Center of Nj
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Lovelace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Montefiore Med.Center, Autism & Obsessive Compulsive Spectrum Prog.
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Duke Center For Autism and Brain Development
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cleveland Clinic, Center For Autism Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44104
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Carolina Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Vanderbilt University Med.Center -Treatment & Research Inst. For Asd
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2551
Country
United States
Facility Name
University of Texas, Houston Dept. of Psychiatry and Behavioral Sciences
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Ericksen Research & Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Neuroscience, Inc.
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Carilion Clinic-Virginia Tech, Carilion School of Medicine
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
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A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
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