A Trial of CM-AT in Children With Autism (CM-AT)

April 17, 2018 updated by: Curemark

A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism

The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Southwest Autism Research and Resource Center
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis, M.I.N.D. Institute
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Santa Ana, California, United States, 92701
        • Neuropsychiatric Research Center of Orange County
    • Florida
      • Orange City, Florida, United States, 32763
        • Lake Mary Pediatrics
    • Georgia
      • Smyrna, Georgia, United States, 30080
        • Institute For Behavioral Medicine
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Science Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peters University Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Oklahoma University Child Study Center
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19124
        • Drexel University
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77054
        • University of Texas, Houston
    • Utah
      • Clinton, Utah, United States, 84015
        • WestSide Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)

Exclusion Criteria:

  • Patient weighing < 11kg (24.2 lbs.)
  • Demonstrated previous allergy to porcine (pork) products
  • Previous history of severe head trauma or stroke, seizure within one year of entering study or uncontrolled systemic disease
  • Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease
  • Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion)
  • Use of of any stimulant medication must be discontinued 5 days prior to entering the study.
  • Subject must have a stable dose of SSRI's for at least 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CM-AT
CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)
Drug: CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Other Names:
  • 900mg CM-AT (pancreatic enzyme concentrate, 720mg
Placebo Comparator: Placebo
Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
Drug: Placebo
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Other Names:
  • 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of changes in behavior scales associated with the core symptoms of autism
Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days
Baseline, 14 days, 30 days, 60 days, 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Other key measures of behavior and quality of life associated with autism
Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days
Baseline, 14 days, 30 days, 60 days, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Curemark

Investigators

  • Principal Investigator: Eugene Arnold, MD MEd., Nisonger Center Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 13, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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