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A Trial of CM-AT in Children With Autism (CM-AT)

Primary Purpose

Autism

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CM-AT
Placebo
Sponsored by
Curemark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest Autism Research and Resource Center
  • University of California, Davis, M.I.N.D. Institute
  • University of California, San Francisco
  • Neuropsychiatric Research Center of Orange County
  • Lake Mary Pediatrics
  • Institute for Behavioral Medicine
  • Alexian Brothers Center for Psychiatric Research
  • Louisiana State University Health Science Center
  • Saint Peters University Hospital
  • Mount Sinai School of Medicine
  • University of North Carolina
  • Ohio State University
  • Oklahoma University Child Study Center
  • Cyn3rgy Research
  • Hershey Medical Center
  • Drexel University
  • University of Pittsburgh
  • University of Texas, Houston
  • Westside Medical

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CM-AT

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2009
Last Updated
April 17, 2018
Sponsor
Curemark
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1. Study Identification

Unique Protocol Identification Number
NCT00881452
Brief Title
A Trial of CM-AT in Children With Autism
Acronym
CM-AT
Official Title
A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Curemark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CM-AT
Arm Type
Active Comparator
Arm Description
CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
Intervention Type
Drug
Intervention Name(s)
CM-AT
Other Intervention Name(s)
900mg CM-AT (pancreatic enzyme concentrate, 720mg
Intervention Description
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
Intervention Description
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Primary Outcome Measure Information:
Title
Evidence of changes in behavior scales associated with the core symptoms of autism
Time Frame
Baseline, 14 days, 30 days, 60 days, 90 days
Secondary Outcome Measure Information:
Title
Other key measures of behavior and quality of life associated with autism
Time Frame
Baseline, 14 days, 30 days, 60 days, 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Arnold, MD MEd.
Organizational Affiliation
Nisonger Center Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Autism Research and Resource Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California, Davis, M.I.N.D. Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Lake Mary Pediatrics
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Institute for Behavioral Medicine
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Louisiana State University Health Science Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Saint Peters University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma University Child Study Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
University of Texas, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Westside Medical
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18305076
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.
Results Reference
background
PubMed Identifier
18056691
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. doi: 10.1177/0883073807307102. Epub 2007 Dec 3.
Results Reference
background
PubMed Identifier
18645422
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.
Results Reference
background
PubMed Identifier
19027584
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.
Results Reference
background
PubMed Identifier
12352252
Citation
Horvath K, Perman JA. Autistic disorder and gastrointestinal disease. Curr Opin Pediatr. 2002 Oct;14(5):583-7. doi: 10.1097/00008480-200210000-00004.
Results Reference
background
PubMed Identifier
16157555
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):987-991. doi: 10.1099/jmm.0.46101-0.
Results Reference
background
PubMed Identifier
12846385
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. doi: 10.1177/1362361303007002004.
Results Reference
background
PubMed Identifier
16628080
Citation
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.
Results Reference
background
PubMed Identifier
15800379
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. doi: 10.1385/JMN:25:3:259.
Results Reference
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A Trial of CM-AT in Children With Autism

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