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Autism drug CM-AT shows promise in reducing irritability

NCT ID NCT02649959

Disease control Sponsor: Curemark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a drug called CM-AT in children with autism who have low levels of a digestive enzyme. The goal is to see if the drug is safe and helps with behaviors like irritability and social withdrawal over a longer period. About 405 children aged 3 to 8 who completed a previous study are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CM-AT (a powder taken three times a day)
What this could lead to
If it works, this could provide a treatment option to reduce irritability and social withdrawal in some children with autism.
What could go wrong
This is an extension study, not a new trial, and results may not apply to all children with autism. The drug may not show clear benefits or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 405 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2015

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism

Contacts and locations

Locations

  • A.P.G. Research

    Orlando, Florida, 32803, United States

  • Advent Health -Lake Mary Pediatrics

    Orange City, Florida, 32763, United States

  • Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)

    Little Rock, Arkansas, 72202, United States

  • Carilion Clinic-Virginia Tech, Carilion School of Medicine

    Roanoke, Virginia, 24014, United States

  • Carolina Clinical Trials, Inc.

    Charleston, South Carolina, 29407, United States

  • Children'S Specialized Hospital

    Egg Harbor, New Jersey, 08234, United States

  • Children's Specialized Hospital

    Toms River, New Jersey, 08755, United States

  • Cleveland Clinic Autism Center

    Cleveland, Ohio, 44104, United States

  • Clinical Research Center of Nj

    Voorhees Township, New Jersey, 08043, United States

  • Detroit Clinical Research Center, P.C.

    Bingham Farms, Michigan, 48025, United States

  • Duke Center For Autism and Brain Development

    Durham, North Carolina, 27705, United States

  • Focus Center of Clinical Research

    Clinton, Utah, 84015, United States

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112, United States

  • L.S.U. Health Sciences Center

    Shreveport, Louisiana, 71103, United States

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629, United States

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108, United States

  • M.I.N.D. Institute (Univ.of California, Davis)

    Sacramento, California, 95817, United States

  • Montefiore Med.Cneter, Autism & Obsessive Compulsive Spectrum Program

    The Bronx, New York, 10467, United States

  • N.R.C. Research Institute

    Orange, California, 92868, United States

  • Neuroscience, Inc

    Herndon, Virginia, 20170, United States

  • Omega Medical Research

    Warwick, Rhode Island, 02886, United States

  • Research Institute of Deaconess Clinic

    Newburgh, Indiana, 47630, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10312, United States

  • Segal Institute For Clinical Research

    North Miami, Florida, 33161, United States

  • Southwest Autism Research & Resource Center (S.A.R.R.C.)

    Phoenix, Arizona, 85006, United States

  • University of Arizona, Pediatrics Multidisciplinary Research Unit

    Tucson, Arizona, 85724, United States

  • University of California (U.C.S.F.)

    San Francisco, California, 94143-0984, United States

  • University of Texas, Houston-Behavioral & Biomedical Sciences

    Houston, Texas, 77054, United States

  • University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences

    Charlottesville, Virginia, 22903, United States

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

    Nashville, Tennessee, 37232-2551, United States

  • Yale Child Study Center

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.