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

This study is currently recruiting participants.
Verified April 2013 by Curemark
Sponsor:
Information provided by (Responsible Party):
Curemark
ClinicalTrials.gov Identifier:
NCT00912691
First received: June 2, 2009
Last updated: April 17, 2013
Last verified: April 2013
History of Changes

June 2, 2009
April 17, 2013
January 2010
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00912691 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
A Trial of CM-AT in Children With Autism- Open Label Extension Study
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.

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.
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autism
Drug: CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Experimental: 1
CM-AT
Intervention: Drug: CM-AT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
January 2014
December 2013   (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)
  • 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
Both
9 Years to 12 Years
No
Not Provided
United States
 
NCT00912691
00102/Autism
Yes
Curemark
Curemark
Not Provided
Principal Investigator: Eugene Arnold, MD Ohio State University, Nisonger Center
Curemark
April 2013

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