AutismPhase 3CM-ATNCT00881452
A Trial of CM-AT in Children With Autism
A Phase 3 study testing CM-AT in people with Autism, run by Curemark at 19 sites in United States.
Trial summary
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Autism
- What is being tested?
- CM-AT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2009to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of North Carolina
Chapel Hill, North Carolina, 27514
Westside Medical
Clinton, Utah, 84015
Ohio State University
Columbus, Ohio, 43210
Cyn3rgy Research
Gresham, Oregon, 97030
Hershey Medical Center
Hershey, Pennsylvania, 17033
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
University of Texas, Houston
Houston, Texas, 77054
Saint Peters University Hospital
New Brunswick, New Jersey, 08901
Mount Sinai School of Medicine
New York, New York, 10029
Oklahoma University Child Study Center
Oklahoma City, Oklahoma, 73117
Lake Mary Pediatrics
Orange City, Florida, 32763
Drexel University
Philadelphia, Pennsylvania, 19124
Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
University of California, Davis, M.I.N.D. Institute
Sacramento, California, 95817
University of California, San Francisco
San Francisco, California, 94143
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701
Louisiana State University Health Science Center
Shreveport, Louisiana, 71103
Institute for Behavioral Medicine
Smyrna, Georgia, 30080
About this study
Official title: A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.
Read the 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.
- Conditions
- Autism
- Being tested
- CM-AT, Placebo
- Keywords
- Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-ATDrug
Also called 900mg CM-AT (pancreatic enzyme concentrate, 720mg
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
PlaceboDrug
Also called 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
Single unit dose powder of non-active substance administered 3 times per day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| CM-AT | Active comparator | CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg) Receives: Drug: CM-AT |
| Placebo | Placebo comparator | Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of changes in behavior scales associated with the core symptoms of autism
Measured: Baseline, 14 days, 30 days, 60 days, 90 days
Secondary outcomes (1)
Other key measures of behavior and quality of life associated with autism
Measured: Baseline, 14 days, 30 days, 60 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curemark
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Arnold, MD MEd., Principal investigator, Nisonger Center Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881452
- Sponsor's protocol ID
- 00101
- Acronym
- CM-AT
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2009
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18305076Xue 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.
PubMed 18056691Simonoff 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.
PubMed 18645422Valicenti-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.
PubMed 19027584Horvath K, Perman JA. Autistic disorder and gastrointestinal disease. Curr Opin Pediatr. 2002 Oct;14(5):583-7. doi: 10.1097/00008480-200210000-00004.
PubMed 12352252Parracho 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.
PubMed 16157555Molloy 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.
PubMed 12846385Borowitz 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.
PubMed 16628080Welch 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.
PubMed 15800379
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism
- ClinicalTrials.gov ID
- NCT00881452
- Acronym / sponsor ID
- CM-AT / 00101
- Conditions
- Autism
- Keywords
- Autism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- CuremarkIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM-AT | Active comparator | Drug: CM-ATCM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM-ATAlso: 900mg CM-AT (pancreatic enzyme concentrate, 720mgSingle unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days | Drug | CM-AT |
| PlaceboAlso: 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)Single unit dose powder of non-active substance administered 3 times per day for 90 days | Drug | Placebo |
Primary outcome
Evidence of changes in behavior scales associated with the core symptoms of autism
Time frame: Baseline, 14 days, 30 days, 60 days, 90 days
1 secondary outcome
Other key measures of behavior and quality of life associated with autism
Time frame: Baseline, 14 days, 30 days, 60 days, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Background: PubMed 18305076Caronna 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.
- Background: PubMed 18056691Xue 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.
- Background: PubMed 18645422Simonoff 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.
- Background: PubMed 19027584Valicenti-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.
- Background: PubMed 12352252Horvath K, Perman JA. Autistic disorder and gastrointestinal disease. Curr Opin Pediatr. 2002 Oct;14(5):583-7. doi: 10.1097/00008480-200210000-00004.
- Background: PubMed 16157555Parracho 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.
- Background: PubMed 12846385Molloy 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.
- Background: PubMed 16628080Borowitz 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.
- Background: PubMed 15800379Welch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Arnold, MD MEd. principal investigator
Nisonger Center Ohio State University
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CM-AT in people with Autism, run by Curemark at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of changes in behavior scales associated with the core symptoms of autism (time frame: Baseline, 14 days, 30 days, 60 days, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00881452, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.