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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00881452
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Curemark

Tracking Information
First Submitted Date  ICMJE April 13, 2009
First Posted Date  ICMJE April 15, 2009
Last Update Posted Date April 19, 2018
Study Start Date  ICMJE May 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
Evidence of changes in behavior scales associated with the core symptoms of autism [ Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
Other key measures of behavior and quality of life associated with autism [ Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of CM-AT in Children With Autism
Official Title  ICMJE A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism
Brief Summary The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • Drug: CM-AT
    Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
    Other Name: 900mg CM-AT (pancreatic enzyme concentrate, 720mg
  • Drug: Placebo
    Single unit dose powder of non-active substance administered 3 times per day for 90 days
    Other Name: 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
Study Arms  ICMJE
  • Active Comparator: CM-AT
    CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)
    Intervention: Drug: CM-AT
  • Placebo Comparator: Placebo
    Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2012)
182
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2009)
170
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00881452
Other Study ID Numbers  ICMJE 00101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Curemark
Study Sponsor  ICMJE Curemark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eugene Arnold, MD MEd. Nisonger Center Ohio State University
PRS Account Curemark
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP