A Trial of CM-AT in Children With Autism

NCT00881452 | Completed Phase 3

• 1 other identifier: 00101
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Autism

Keywords

Autism

Outcome Measures

Primary Outcomes (1)

• Evidence of changes in behavior scales associated with the core symptoms of autism

  Baseline, 14 days, 30 days, 60 days, 90 days

Secondary Outcomes (1)

• Other key measures of behavior and quality of life associated with autism

  Baseline, 14 days, 30 days, 60 days, 90 days

Study Arms (2)

CM-AT

ACTIVE COMPARATOR

CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)

Drug: CM-AT

Placebo

PLACEBO COMPARATOR

Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)

Drug: Placebo

Interventions

CM-AT DRUG

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

Also known as: 900mg CM-AT (pancreatic enzyme concentrate, 720mg

CM-AT

Placebo DRUG

Single unit dose powder of non-active substance administered 3 times per day for 90 days

Also known as: 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)

Placebo

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Curemark: lead

Study Sites (19)

Southwest Autism Research and Resource Center

Phoenix, Arizona, 85006, United States

Location

University of California, Davis, M.I.N.D. Institute

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Lake Mary Pediatrics

Orange City, Florida, 32763, United States

Location

Institute for Behavioral Medicine

Smyrna, Georgia, 30080, United States

Location

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Louisiana State University Health Science Center

Shreveport, Louisiana, 71103, United States

Location

Saint Peters University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma University Child Study Center

Oklahoma City, Oklahoma, 73117, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19124, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Texas, Houston

Houston, Texas, 77054, United States

Location

Westside Medical

Clinton, Utah, 84015, United States

Location

Related Publications (9)

• 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.

  PMID: 18305076 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.

  PMID: 18056691 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.

  PMID: 18645422 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.

  PMID: 19027584 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.

  PMID: 12352252 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.

  PMID: 16157555 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.

  PMID: 12846385 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.

  PMID: 16628080 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.

  PMID: 15800379 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

Citric Acid

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Eugene Arnold, MD MEd.

  Nisonger Center Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

US (19)