CM-AT for Autism

Recruiting at 31 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Curemark

Must not be taking: Stimulants, Non-stimulants, ADHD meds

Disqualifiers: Seizures, Severe trauma, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

405 Participants Needed

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.

Will I have to stop taking my current medications?

If you are taking medication for ADHD, you must stop 5 days before the study starts. If you are on an SSRI, you need to be on a stable dose for at least 30 days before joining the study.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CM-AT, a proprietary enzyme, taken as a granulated powder three times daily

12 weeks

Open-label extension

Continued evaluation of the safety and efficacy of CM-AT in pediatric patients with autism

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CM-AT

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+