CM-AT for Autism

Recruiting at31 trial locations

Overseen by Robert Hendren, DO

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Curemark

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a special enzyme powder called CM-AT to help children with autism digest protein better.

Research Team

Deborah Pearson, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Robert Hendren, DO

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for children with autism aged 3-8 who participated in a prior study (Sponsor's 00103 Study) or are currently in the open label study (00102). It also includes new participants aged 9-17 meeting DSM-IV-TR criteria for Autistic Disorder. Exclusions include severe head trauma, allergy to porcine products, SSRI use without stable dosing, significant systemic disease, dietary restrictions except nut allergies and lactose-free diets, weight under 13kg, trypsin sensitivities/allergies, ADHD medication use within five days of starting the trial.

Inclusion Criteria

I am between 9-17 years old and have been diagnosed with Autism.

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

Exclusion Criteria

I have had a severe head injury, including loss of consciousness, hospitalization, skull fracture, or stroke.

Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose free is allowable but not dairy free

History of premature birth <35 weeks gestation

Treatment Details

Interventions

• CM-AT (Other)

Trial Overview The clinical trial is testing CM-AT on pediatric patients with autism to evaluate its safety and effectiveness over time. This Phase III trial allows all levels of fecal chymotrypsin among participants and does not involve a control group as it is an open-label extension study.

Participant Groups

Group I: Open Label Experimental Treatment 1 Intervention

CM-AT

Who Is Running the Clinical Trial?

Curemark

Lead Sponsor

Trials

4

Recruited

940+