A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
NCT ID: NCT02410902
Last Updated: 2023-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
190 participants
INTERVENTIONAL
2015-05-13
2017-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CM-AT
Active substance in single unit dose powder
CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Placebo
Placebo powder of inactive substance
PLACEBO
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Interventions
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CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
PLACEBO
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
3 Years
8 Years
ALL
Yes
Sponsors
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Curemark
INDUSTRY
Responsible Party
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Principal Investigators
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Deborah Pearson, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Robert Hendren, DO
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Southwest Autism Research & Resource Center (S.A.R.R.C.)
Phoenix, Arizona, United States
University of Arizona, Pediatrics Multidisciplinary Research Unit
Tucson, Arizona, United States
Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)
Little Rock, Arkansas, United States
N.R.C. Research Institute
Orange, California, United States
M.I.N.D. Institute (Univ.of California, Davis)
Sacramento, California, United States
University of California (U.C.S.F.)
San Francisco, California, United States
IMMUNOe RESEARCH CENTERS
Centennial, Colorado, United States
Yale Child Study Center
New Haven, Connecticut, United States
Segal Institute For Clinical Research
North Miami, Florida, United States
Florida Hospital Medical Group-Lake Mary Pediatrics
Orange City, Florida, United States
Kaley Kildahl
Orlando, Florida, United States
Research Institute of Deaconess Clinic
Evansville, Indiana, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
L.S.U. Health Sciences Center
Shreveport, Louisiana, United States
Detroit Clinical Research Center, P.C.
Bingham Farms, Michigan, United States
Children'S Specialized Hospital
Egg Harbor, New Jersey, United States
Children'S Specialized Hospital
Toms River, New Jersey, United States
Clinical Research Center of Nj
Voorhees Township, New Jersey, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Montefiore Med.Center, Autism & Obsessive Compulsive Spectrum Prog.
The Bronx, New York, United States
Duke Center For Autism and Brain Development
Durham, North Carolina, United States
Cleveland Clinic, Center For Autism Research
Cleveland, Ohio, United States
Omega Medical Research
Warwick, Rhode Island, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States
Vanderbilt University Med.Center -Treatment & Research Inst. For Asd
Nashville, Tennessee, United States
University of Texas, Houston Dept. of Psychiatry and Behavioral Sciences
Houston, Texas, United States
Ericksen Research & Development
Clinton, Utah, United States
University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences
Charlottesville, Virginia, United States
Neuroscience, Inc.
Herndon, Virginia, United States
Carilion Clinic-Virginia Tech, Carilion School of Medicine
Roanoke, Virginia, United States
Countries
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References
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Developmental Disabilities Monitoring Network Surveillance Year 2010 Principal Investigators; Centers for Disease Control and Prevention (CDC). Prevalence of autism spectrum disorder among children aged 8 years - autism and developmental disabilities monitoring network, 11 sites, United States, 2010. MMWR Surveill Summ. 2014 Mar 28;63(2):1-21.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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00103
Identifier Type: -
Identifier Source: org_study_id
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