Summary

for people ages 3-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
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 Autistic Disorder CM-AT Open Label

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

Lead Scientist

  • Robert Hendren
    Robert L. Hendren, D.O., is Professor of Psychiatry and Behavioral Science; Division of Child and Adolescent Psychiatry; Co-Director of the UCSF Dyslexia Center; and Director, Neurodevelopmental, Translational Outcomes Research Program (NTORP). He works in the STAR Autism and Neurodevelopmental Disorders Program.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Curemark
ID
NCT02649959
Phase
Phase 3
Study Type
Interventional
Last Updated