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Summary

for people ages 3–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

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 Autistic Disorder

Eligibility

You can join if…

Open to people ages 3–17

  • Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in Sponsor 00103 Study
  • Completion of the Sponsor's 00103 Study who continue to meet eligibility requirements
  • 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
  • Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R

You CAN'T join if...

  • Patient weighing < 13kg
  • Allergy to porcine products
  • Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase
  • History of severe head trauma, as defined by loss of consciousness or hospitalization,skull fracture or stroke.
  • Seizure within the last year prior to enrollment, or the need for seizure medications either at present or in the past.
  • Evidence or history of severe, moderate or uncontrolled systemic disease
  • Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose free is allowable but not dairy free.
  • Inability to ingest the study drug / non-compliance with dosing schedule.
  • Inability to follow the prescribed dosing schedule.
  • Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to the initial randomized study period.
  • Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days prior to entering the study.
  • History of premature birth <35 weeks gestation.
  • Prior history of stroke in utero or other in utero insult.

Locations

  • University of California (U.C.S.F.) accepting new patients
    San Francisco, California, 94143-0984, United States
  • M.I.N.D. Institute (Univ.of California, Davis) accepting new patients
    Sacramento, California, 95817, United States
  • N.R.C. Research Institute in progress, not accepting new patients
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Curemark
ID
NCT02649959
Phase
Phase 3
Lead Scientist
Robert Hendren
Study Type
Interventional
Last Updated
July 18, 2017
I’m interested in this study!