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

Sponsor:	Curemark
Information provided by:	Curemark
ClinicalTrials.gov Identifier:	NCT00881452

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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 ]

Estimated Enrollment:	170
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Kristin Walsh, RN MSN

914-925-3450

kristin.walsh@curemark.com

Locations

United States, Arizona
Southwest Autism Research and Resource Center	Recruiting
Phoenix, Arizona, United States, 85006
Contact: Sarah Brautigam, MPH 602-218-8196 sbrautigam@autismcenter.org
Principal Investigator: Raun Melmed, MD
United States, California
University of California, Davis, M.I.N.D. Institute	Recruiting
Sacramento, California, United States, 95817
Contact: Mandy M. Pietrykowski, BA 916-703-0391 mandy.pietrykowski@ucdmc.ucdavis.edu
Principal Investigator: Randi Hagerman, MD
United States, Florida
Lake Mary Pediatrics	Recruiting
Orange City, Florida, United States, 32763
Contact: Heidi Anderson, RN 386-960-8282 cclinical2@aol.com
Contact: Liz Vieco, LPN 386-960-8282 cclinical1@aol.com
Principal Investigator: Miles Landis, MD
United States, Illinois
Alexian Brothers Center for Psychiatric Research	Recruiting
Hoffman Estates, Illinois, United States, 60169
Contact: Melissa Sullivan, CCRC 847-230-3992 Melissa.Sullivan@abbhh.net
Principal Investigator: Mark Lerman, MD
United States, Indiana
Indiana University, Purdue University Indianapolis	Withdrawn
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana State University Health Science Center	Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Kelly Hoffman, BS 318-813-2082 khoff2@lsuhsc.edu
Principal Investigator: Jasjit Singh, MD
United States, New Jersey
Saint Peters University Hospital	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Sandra Samu, RN ssamu@saintpetersuh.com
Principal Investigator: Barbie Zimmerman-Bier, MD
United States, New York
Mount Sinai School of Medicine	Recruiting
NY, New York, United States, 10029
Contact: Sarah Soffes, BA 212-241-2993 sarah.soffes@mssm.edu
Principal Investigator: Alexander Kolevzon, MD
United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Lindsey Hazzard, MSW 919-843-2084 lhazzard@med.unc.edu
Principal Investigator: Lin Sikich, MD
United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Contact: Monica L. Mitchell, BA 614-247-6402 monica.mitchell@osumc.edu
Principal Investigator: Eugene Arnold, MD
United States, Pennsylvania
Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Julie Vallati, LPN 717-531-1260 jvallati@hmc.psu.edu
Principal Investigator: Jeanette Ramer, MD
Drexel University	Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Melissa Lech, RN 215-831-4058 Melissa.Lech@DrexelMed.edu
Principal Investigator: Richard Malone, MD
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Sarah McAuliffe-Bellin, M.Ed 412-235-5408 mcauliffebellinsj@upmc.edu
Principal Investigator: Benjamin Handen, MD
United States, Texas
University of Texas, Houston	Recruiting
Houston, Texas, United States, 77054
Contact: Rosleen Mansour, MA 713-486-2591 Rosleen.Mansour@uth.tmc.edu
Principal Investigator: Deborah Pearson, PhD

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 ( William E. Gannon Jr. MD Medical Director )
ClinicalTrials.gov Identifier:	NCT00881452 History of Changes
Other Study ID Numbers:	00101
Study First Received:	April 13, 2009
Last Updated:	August 25, 2010
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 September 01, 2010