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Trial record 1 of 1 for:    NCT00881452
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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

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

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism
Study Start Date : May 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 2011
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CM-AT
CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)
 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
Placebo Comparator: Placebo
Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
 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)


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, 14 days, 30 days, 60 days, 90 days ]

Secondary Outcome Measures :
  1. Other key measures of behavior and quality of life associated with autism [ Time Frame: Baseline, 14 days, 30 days, 60 days, 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 8 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)

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.
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): NCT00881452


Locations
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Sponsors and Collaborators
Curemark
Investigators
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Principal Investigator: Eugene Arnold, MD MEd. Nisonger Center Ohio State University
More Information
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Publications:

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Responsible Party: Curemark
ClinicalTrials.gov Identifier: NCT00881452    
Other Study ID Numbers: 00101
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
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
Citric Acid
 Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action