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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Curemark
ClinicalTrials.gov Identifier:
NCT00912691
First received: June 2, 2009
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Autism
Drug: CM-AT
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Open Label Extension Study of CM-AT in Children With Autism

Resource links provided by NLM:


Further study details as provided by Curemark:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 170
Study Start Date: January 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CM-AT
Drug: CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

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.

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912691

Locations
United States, Arizona
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
United States, California
University of California, Davis, M.I.N.D. Institute
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94143
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States, 92701
United States, Florida
Lake Mary Pediatrics
Orange City, Florida, United States, 32763
United States, Georgia
Institute for Behavioral Medicine
Symrna, Georgia, United States, 30080
United States, Illinois
Alexian Brothers Center for Psychiatric Research
Hoffman Estates,, Illinois, United States, 60169
United States, Louisiana
Louisiana State University
Shreveport, Louisiana, United States, 71103
United States, New Jersey
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New York
Mount Sinai School of Medicine
Manhattan, New York, United States, 10029
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma State University, Child Study Center
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
Cyn3rgy Research Center
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Drexel University
Philadelphia, Pennsylvania, United States, 19124
Universtiy of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, Texas
University of Texas, Houston
Houston, Texas, United States, 77054
United States, Utah
Ericksen Research & Development
Clinton, Utah, United States, 84015
Sponsors and Collaborators
Curemark
Investigators
Principal Investigator: Eugene Arnold, MD Ohio State University, Nisonger Center
  More Information

No publications provided

Responsible Party: Curemark
ClinicalTrials.gov Identifier: NCT00912691     History of Changes
Other Study ID Numbers: 00102/Autism
Study First Received: June 2, 2009
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Curemark:
Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on October 21, 2014