🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT02649959
Active, not recruiting Phase 3

An Open Label Study of CM-AT for the Treatment of Children With Autism

NCT02649959 · tracked via the Priya Life Science USA tracker
Sponsor
Curemark
Phase
Phase 3
Started
2015-10
Last updated
2026-03-18

Condition(s) studied

Autism

Investigational drug(s) / intervention(s)

CM-AT

CM-AT: Single unit does powder of active substance (CM-AT) administered 3 times per day

Study summary

This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.

Eligibility

Sex
ALL
Min age
3 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in Sponsor 00103 Study * Completion of the Sponsor's 00103 Study who continue to meet eligibility requirements * Currently in the 00102 open label study and continue to meet eligibility requirements * Subjects who initially qualified for 00103 screening, who subsequently failed Baseline entrance criteria for randomization (@Visit 1) Baseline assessment of the ABC eligibility requirement who continue to meet eligibility requirements * Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R Exclusion Criteria: * Patient weighing \< 13kg * Allergy to porcine products * Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase * History of severe head trauma, as defined by loss of consciousness or hospitalization, skull fracture or stroke. * Seizure within the last year prior to enrollment, or the need for seizure medications either at present or in the past. * Evidence or history of severe, moderate or uncontrolled systemic disease * Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose free is allowable but not dairy free. * Inability to ingest the study drug / non-compliance with dosing schedule. * Inability to follow the prescribed dosing schedule. * Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to the initial randomized study period. * Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days prior to entering the study. * History of premature birth \<35 weeks gestation. * Prior history of stroke in utero or other in utero insult.

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
Southwest Autism Research & Resource Center (S.A.R.R.C.) Phoenix Arizona
University of Arizona, Pediatrics Multidisciplinary Research Unit Tucson Arizona
Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.) Little Rock Arkansas
N.R.C. Research Institute Orange California
M.I.N.D. Institute (Univ.of California, Davis) Sacramento California
University of California (U.C.S.F.) San Francisco California
IMMUNOe Research Centers Centennial Colorado
Yale Child Study Center New Haven Connecticut
Segal Institute For Clinical Research North Miami Florida
Advent Health -Lake Mary Pediatrics Orange City Florida
A.P.G. Research Orlando Florida
Research Institute of Deaconess Clinic Newburgh Indiana
Lake Charles Clinical Trials Lake Charles Louisiana
L.S.U. Health Sciences Center Shreveport Louisiana
Detroit Clinical Research Center, P.C. Bingham Farms Michigan
Children'S Specialized Hospital Egg Harbor New Jersey
Children's Specialized Hospital Toms River New Jersey
Clinical Research Center of Nj Voorhees Township New Jersey
Lovelace Scientific Resources Albuquerque New Mexico
Richmond Behavioral Associates Staten Island New York
Montefiore Med.Cneter, Autism & Obsessive Compulsive Spectrum Program The Bronx New York
Duke Center For Autism and Brain Development Durham North Carolina
Cleveland Clinic Autism Center Cleveland Ohio
Omega Medical Research Warwick Rhode Island
Carolina Clinical Trials, Inc. Charleston South Carolina
Vanderbilt Universtiy Med.Center-Treatment&Research Inst. For Asd Nashville Tennessee
University of Texas, Houston-Behavioral & Biomedical Sciences Houston Texas
Focus Center of Clinical Research Clinton Utah
University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences Charlottesville Virginia
Neuroscience, Inc Herndon Virginia
Carilion Clinic-Virginia Tech, Carilion School of Medicine Roanoke Virginia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02649959 on ClinicalTrials.gov ↗ ← All trials in the USA