A Trial of CM-AT in Children With Autism- Open Label Extension Study (CM-AT)

February 26, 2019 updated by: Curemark

A Phase III Open Label Extension Study of CM-AT in Children With Autism

The purpose of this study is to determine whether CM-AT is 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. CM-AT 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. It is formulated to be released in the small intestine to enhance protein digestion thus increasing the availability of essential amino acids.

Study Type

Interventional

Enrollment (Actual)

165

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
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
    • New York
      • Manhattan, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina, Chapel Hill
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Oklahoma State University, Child Study Center
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19124
        • Drexel University
      • Pittsburgh, Pennsylvania, United States, 15260
        • Universtiy of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77054
        • University of Texas, Houston
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research & Development

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

9 years to 12 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)
  • Ongoing 00102 Protocol required completion of 00101 Protocol
  • Now recruiting subjects directly into 00102 Protocol

Exclusion Criteria:

  • Ongoing study required patients to be 3-8 years old weighing < 11kg (24.2 lbs.), and achieving ages 9-12 years old weighing < 22kg (48.4 lbs.).
  • Newly recruited subjects must be between ages 9 - 12 years old weighing < 22kgs (48.4 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)
  • Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CM-AT
Drug: CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

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, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks
Baseline, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Other key measures of behavior and quality of life associated with autism
Time Frame: Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks
Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks

Collaborators and Investigators

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

Sponsor

Curemark

Investigators

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

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 (Actual)

January 1, 2010

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00102/Autism

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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