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

Running, not enrolling · Phase 3

Conditions studied: Autism

In brief

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.

Key facts

Study ID

NCT02649959

Run by

Curemark

People needed

405

Starts

2015-10-01

Expected to finish

2028-01-01

Last updated by the study team

2026-03-18

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Advent Health -Lake Mary Pediatrics — Orange City, Florida, United States
• A.P.G. Research — Orlando, Florida, United States
• Research Institute of Deaconess Clinic — Newburgh, 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.Cneter, Autism & Obsessive Compulsive Spectrum Program — The Bronx, New York, United States
• Duke Center For Autism and Brain Development — Durham, North Carolina, United States
• Cleveland Clinic Autism Center — Cleveland, Ohio, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• Carolina Clinical Trials, Inc. — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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