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A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)

NCT02410902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2023-05-24

Study results available
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Summary

The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.

Conditions

Interventions

DRUG

CM-AT

Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

DRUG

PLACEBO

Single unit dose powder of non-active substance administered 3 times per day for 90 days

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
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-13
Primary Completion
2017-12-22
Completion
2017-12-22

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02410902 on ClinicalTrials.gov