Summary

Eligibility
for people ages 3-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Robert Hendren, DO
Headshot of Robert Hendren
Robert Hendren

Description

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.

Official Title

An Open-Label Extension Study of CM-AT for the Treatment of Children With Autism With All Levels of Fecal Chymotrypsin

Details

Autism is clearly a significant cause of disability in the pediatric population. Treatment is based on the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.

Keywords

Autism, A long-term extension study in a pediatric population of children with autism., Autistic Disorder, Open Label

Eligibility

Locations

  • University of California (U.C.S.F.)
    San Francisco California 94143-0984 United States
  • M.I.N.D. Institute (Univ.of California, Davis)
    Sacramento California 95817 United States

Lead Scientist at UCSF

  • Robert Hendren, DO
    Robert L. Hendren, D.O., is Professor of Psychiatry and Behavioral Science Emeritus 2023; Division of Child and Adolescent Psychiatry; Co-Director of the UCSF Dyslexia Center 2013-2023; and Director, Program for Research on Neurodevelopmental, Translational Outcomes (PRONTO) http://hendrenlab.ucsf.edu 2011-2023.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Curemark
ID
NCT02649959
Phase
Phase 3 Autism Research Study
Study Type
Interventional
Participants
Expecting 405 study participants
Last Updated