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ACTIVE NOT RECRUITING
NCT02649959
PHASE3

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

Sponsor: Curemark

View on ClinicalTrials.gov

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.

Official title: An Open-Label Extension Study of CM-AT for the Treatment of Children With Autism With All Levels of Fecal Chymotrypsin

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

405

Start Date

2015-10

Completion Date

2028-01

Last Updated

2026-03-18

Healthy Volunteers

No

Conditions

Interventions

DRUG

CM-AT

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

Locations (31)

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

Vanderbilt Universtiy Med.Center-Treatment&Research Inst. For Asd

Nashville, Tennessee, United States

University of Texas, Houston-Behavioral & Biomedical Sciences

Houston, Texas, United States

Focus Center of Clinical Research

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