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

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ClinicalTrials.gov Identifier: NCT02649959
Recruitment Status : Active, not recruiting
First Posted : January 8, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Curemark

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Drug: CM-AT Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of CM-AT for the Treatment of Children With Autism With All Levels of Fecal Chymotrypsin
Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Open Label
CM-AT
Drug: CM-AT
Single unit does powder of active substance (CM-AT) administered 3 times per day




Primary Outcome Measures :
  1. Aberrant Behavioral Checklist: Subscale of Irritability / Agitation (ABC-I) at fecal chymotrypsin (FCT) levels less than or equal to 12.6 [ Time Frame: Change from Baseline to each post-baseline visit, through study completion Week 72. ]

Secondary Outcome Measures :
  1. Aberrant Behavior Checklist: Subscale of Lethargy / Social Withdrawal (ABC-L) at fecal chymotrypsin (FCT) levels less than or equal to 12.6 [ Time Frame: Change from Baseline to each post-baseline visit, through study completion Week 72. ]


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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649959


  Show 31 Study Locations
Sponsors and Collaborators
Curemark
Investigators
Principal Investigator: Deborah Pearson, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Robert Hendren, DO University of California, San Francisco

Publications:
Baio, J. Prevalence of Autism Spectrum Disorders - Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States. (2008), Retrieved from http://www.cdc.gov/mmwr/pdf/ss/ss6103.pdf
Baio, J. Prevalence of Autism Spectrum Disorders - Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States.(2010). Retrieved from http://www.cdc.gov/mmwr/pdf/ss/ss6302.pdf

Responsible Party: Curemark
ClinicalTrials.gov Identifier: NCT02649959     History of Changes
Other Study ID Numbers: 00104/Open Label-Autism
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Curemark:
Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders