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A Trial of CM-AT in Children With Autism- Open Label Extension Study (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: NCT00912691
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Curemark

Study Description
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Brief Summary:
The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.

Condition or disease Intervention/treatment Phase
Autism Drug: CM-AT Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Open Label Extension Study of CM-AT in Children With Autism
Actual Study Start Date : January 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912691


Locations
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Sponsors and Collaborators
Curemark
Investigators
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Principal Investigator: Eugene Arnold, MD Ohio State University, Nisonger Center
More Information
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Responsible Party: Curemark
ClinicalTrials.gov Identifier: NCT00912691    
Other Study ID Numbers: 00102/Autism
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Curemark:
Autism
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders