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A Trial of CM-AT in Children With Autism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Curemark
ClinicalTrials.gov Identifier:
NCT00881452
First received: April 13, 2009
Last updated: March 11, 2013
Last verified: March 2013

April 13, 2009
March 11, 2013
May 2009
June 2011   (final data collection date for primary outcome measure)
Evidence of changes in behavior scales associated with the core symptoms of autism [ Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881452 on ClinicalTrials.gov Archive Site
Other key measures of behavior and quality of life associated with autism [ Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial of CM-AT in Children With Autism
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism
  • Drug: CM-AT
    Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
  • Drug: Placebo
    Single unit dose powder of non-active substance administered 3 times per day for 90 days
  • Active Comparator: 1
    CM-AT
    Intervention: Drug: CM-AT
  • Placebo Comparator: 2
    Placebo powder
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
September 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
3 Years to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00881452
00101
No
Curemark
Curemark
Not Provided
Principal Investigator: Eugene Arnold, MD MEd. Nisonger Center Ohio State University
Curemark
March 2013

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