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

NCT02649959 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CM-AT

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

Sponsors & Collaborators

  • Curemark

    lead INDUSTRY

Principal Investigators

  • Deborah Pearson, PhD · The University of Texas Health Science Center, Houston

  • Robert Hendren, DO · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649959 on ClinicalTrials.gov