NCT02649959Active, not recruitingPhase 3
An Open Label Study of CM-AT for the Treatment of Children With Autism
An Open-Label Extension Study of CM-AT for the Treatment of Children With Autism With All Levels of Fecal Chymotrypsin
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 405 (estimated)
- First submitted
- 12 Nov 2015
- Start date
- Oct 2015
- Primary completion date
- Jan 2028
- Lead sponsor
- Curemark
- Diseases
- Autism
- NCT number
- NCT02649959
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 405
- From Oct 2015 to the primary completion date, Jan 2028
- 31 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 3 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lovelace Scientific Resources Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Detroit Clinical Research Center, P.C. Coordinator of this site? Confirm its status | Bingham Farms | United States | Unknown status |
| IMMUNOe Research Centers Coordinator of this site? Confirm its status | Centennial | United States | Unknown status |
| Carolina Clinical Trials, Inc. Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Cleveland Clinic Autism Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Focus Center of Clinical Research Coordinator of this site? Confirm its status | Clinton | United States | Unknown status |
| Duke Center For Autism and Brain Development Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Children'S Specialized Hospital Coordinator of this site? Confirm its status | Egg Harbor | United States | Unknown status |
| Neuroscience, Inc Coordinator of this site? Confirm its status | Herndon | United States | Unknown status |
| University of Texas, Houston-Behavioral & Biomedical Sciences Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Lake Charles Clinical Trials Coordinator of this site? Confirm its status | Lake Charles | United States | Unknown status |
| Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.) Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Vanderbilt Universtiy Med.Center-Treatment&Research Inst. For Asd Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Research Institute of Deaconess Clinic Coordinator of this site? Confirm its status | Newburgh | United States | Unknown status |
| Yale Child Study Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Segal Institute For Clinical Research Coordinator of this site? Confirm its status | North Miami | United States | Unknown status |
| N.R.C. Research Institute Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Advent Health -Lake Mary Pediatrics Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| A.P.G. Research Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Southwest Autism Research & Resource Center (S.A.R.R.C.) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Carilion Clinic-Virginia Tech, Carilion School of Medicine Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| M.I.N.D. Institute (Univ.of California, Davis) Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of California (U.C.S.F.) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| L.S.U. Health Sciences Center Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| Richmond Behavioral Associates Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| Montefiore Med.Cneter, Autism & Obsessive Compulsive Spectrum Program Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Children's Specialized Hospital Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| University of Arizona, Pediatrics Multidisciplinary Research Unit Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Clinical Research Center of Nj Coordinator of this site? Confirm its status | Voorhees Township | United States | Unknown status |
| Omega Medical Research Coordinator of this site? Confirm its status | Warwick | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.