A Trial of CM-AT in Children With Autism

Autism Clinical Trial

— CM-AT  

Official title:

A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881452
• Other study ID #: 00101
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2009
• Last updated: April 17, 2018
• Start date: May 2009
• Est. completion date: September 2011

Study information

• Verified date: April 2018
• Source: Curemark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Drug:
• CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
• Placebo
Single unit dose powder of non-active substance administered 3 times per day for 90 days

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Westside Medical	Clinton	Utah
United States	Ohio State University	Columbus	Ohio
United States	Cyn3rgy Research	Gresham	Oregon
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	University of Texas, Houston	Houston	Texas
United States	Saint Peters University Hospital	New Brunswick	New Jersey
United States	Mount Sinai School of Medicine	New York	New York
United States	Oklahoma University Child Study Center	Oklahoma City	Oklahoma
United States	Lake Mary Pediatrics	Orange City	Florida
United States	Drexel University	Philadelphia	Pennsylvania
United States	Southwest Autism Research and Resource Center	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California, Davis, M.I.N.D. Institute	Sacramento	California
United States	University of California, San Francisco	San Francisco	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	Louisiana State University Health Science Center	Shreveport	Louisiana
United States	Institute for Behavioral Medicine	Smyrna	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Curemark

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

Caronna EB, Milunsky JM, Tager-Flusberg H. Autism spectrum disorders: clinical and research frontiers. Arch Dis Child. 2008 Jun;93(6):518-23. doi: 10.1136/adc.2006.115337. Epub 2008 Feb 27. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. doi: 10.1097/CHI.0b013e318179964f. — View Citation

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. doi: 10.1016/j.pediatrneurol.2008.07.019. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of changes in behavior scales associated with the core symptoms of autism		Baseline, 14 days, 30 days, 60 days, 90 days
Secondary	Other key measures of behavior and quality of life associated with autism		Baseline, 14 days, 30 days, 60 days, 90 days