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The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM-AT | Active Comparator | CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg) |
|
| Placebo | Placebo Comparator | Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM-AT | Drug | Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of changes in behavior scales associated with the core symptoms of autism | Baseline, 14 days, 30 days, 60 days, 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Other key measures of behavior and quality of life associated with autism | Baseline, 14 days, 30 days, 60 days, 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Arnold, MD MEd. | Nisonger Center Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | United States | ||
| University of California, Davis, M.I.N.D. Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18305076 | Background | 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. | |
| 18056691 | Background | 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. doi: 10.1177/0883073807307102. Epub 2007 Dec 3. |
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| Placebo | Drug | Single unit dose powder of non-active substance administered 3 times per day for 90 days |
|
|
| Sacramento |
| California |
| 95817 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Neuropsychiatric Research Center of Orange County | Santa Ana | California | 92701 | United States |
| Lake Mary Pediatrics | Orange City | Florida | 32763 | United States |
| Institute for Behavioral Medicine | Smyrna | Georgia | 30080 | United States |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| Louisiana State University Health Science Center | Shreveport | Louisiana | 71103 | United States |
| Saint Peters University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oklahoma University Child Study Center | Oklahoma City | Oklahoma | 73117 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19124 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| University of Texas, Houston | Houston | Texas | 77054 | United States |
| Westside Medical | Clinton | Utah | 84015 | United States |
| 18645422 | Background | 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. |
| 19027584 | Background | 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. |
| 12352252 | Background | Horvath K, Perman JA. Autistic disorder and gastrointestinal disease. Curr Opin Pediatr. 2002 Oct;14(5):583-7. doi: 10.1097/00008480-200210000-00004. |
| 16157555 | Background | 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):987-991. doi: 10.1099/jmm.0.46101-0. |
| 12846385 | Background | 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. doi: 10.1177/1362361303007002004. |
| 16628080 | Background | 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. doi: 10.1097/01.mpa.0000202952.10612.21. |
| 15800379 | Background | 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. doi: 10.1385/JMN:25:3:259. |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019343 | Citric Acid |
| ID | Term |
|---|---|
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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