A Trial of CM-AT in Children With Autism - Full Text View

Purpose

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

Condition	Intervention	Phase
Autism	Drug: CM-AT Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism

Resource links provided by NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

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, 14 days, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	182
Study Start Date:	May 2009
Study Completion Date:	September 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 CM-AT	Drug: CM-AT Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Placebo Comparator: 2 Placebo powder	Drug: Placebo Single unit dose powder of non-active substance administered 3 times per day for 90 days

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.

Eligibility

Ages Eligible for Study:	3 Years to 8 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)

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881452

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
Smyrna, 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 Health Science Center
Shreveport, Louisiana, United States, 71103
United States, New Jersey
Saint Peters University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New York
Mount Sinai School of Medicine
NY, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma University Child Study Center
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Drexel University
Philadelphia, Pennsylvania, United States, 19124
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, Texas
University of Texas, Houston
Houston, Texas, United States, 77054
United States, Utah
Westside Medical
Clinton, Utah, United States, 84015

Sponsors and Collaborators

Curemark

Investigators

Principal Investigator:

Eugene Arnold, MD MEd.

Nisonger Center Ohio State University

More Information

Publications:

Caronna EB, Milunsky JM, Tager-Flusberg H. Autism spectrum disorders: clinical and research frontiers. Arch Dis Child. 2008 Jun;93(6):518-23. Epub 2008 Feb 27. Review.

Xue Ming, Brimacombe M, Chaaban J, Zimmerman-Bier B, Wagner GC. Autism spectrum disorders: concurrent clinical disorders. J Child Neurol. 2008 Jan;23(1):6-13. Epub 2007 Dec 3.

Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9.

Valicenti-McDermott MD, McVicar K, Cohen HJ, Wershil BK, Shinnar S. Gastrointestinal symptoms in children with an autism spectrum disorder and language regression. Pediatr Neurol. 2008 Dec;39(6):392-8.

Horvath K, Perman JA. Autistic disorder and gastrointestinal disease. Curr Opin Pediatr. 2002 Oct;14(5):583-7. Review.

Parracho HM, Bingham MO, Gibson GR, McCartney AL. Differences between the gut microflora of children with autistic spectrum disorders and that of healthy children. J Med Microbiol. 2005 Oct;54(Pt 10):987-91.

Molloy CA, Manning-Courtney P. Prevalence of chronic gastrointestinal symptoms in children with autism and autistic spectrum disorders. Autism. 2003 Jun;7(2):165-71.

Borowitz D, Goss CH, Stevens C, Hayes D, Newman L, O'Rourke A, Konstan MW, Wagener J, Moss R, Hendeles L, Orenstein D, Ahrens R, Oermann CM, Aitken ML, Mahl TC, Young KR Jr, Dunitz J, Murray FT. Safety and preliminary clinical activity of a novel pancreatic enzyme preparation in pancreatic insufficient cystic fibrosis patients. Pancreas. 2006 Apr;32(3):258-63.

Welch MG, Welch-Horan TB, Anwar M, Anwar N, Ludwig RJ, Ruggiero DA. Brain effects of chronic IBD in areas abnormal in autism and treatment by single neuropeptides secretin and oxytocin. J Mol Neurosci. 2005;25(3):259-74.

Responsible Party:	Curemark
ClinicalTrials.gov Identifier:	NCT00881452 History of Changes
Other Study ID Numbers:	00101
Study First Received:	April 13, 2009
Last Updated:	March 11, 2013
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 Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013