Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
182 participants
INTERVENTIONAL
2009-05-31
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
NCT02410902
Placebo-Controlled Pilot Trial of Mecamylamine for Treatment of Autism Spectrum Disorders
NCT00773812
Cortical Metrics Assessment Outcome Measure Development in Autism With Memantine Treatment
NCT02353130
A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism (MEM)
NCT01372449
Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD
NCT06757504
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CM-AT
CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)
CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Placebo
Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
Placebo
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
3 Years
8 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Curemark
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eugene Arnold, MD MEd.
Role: PRINCIPAL_INVESTIGATOR
Nisonger Center Ohio State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southwest Autism Research and Resource Center
Phoenix, Arizona, 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
Lake Mary Pediatrics
Orange City, Florida, United States
Institute for Behavioral Medicine
Smyrna, Georgia, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Louisiana State University Health Science Center
Shreveport, Louisiana, United States
Saint Peters University Hospital
New Brunswick, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Oklahoma University Child Study Center
Oklahoma City, Oklahoma, United States
Cyn3rgy Research
Gresham, Oregon, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas, Houston
Houston, Texas, United States
Westside Medical
Clinton, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Horvath K, Perman JA. Autistic disorder and gastrointestinal disease. Curr Opin Pediatr. 2002 Oct;14(5):583-7. doi: 10.1097/00008480-200210000-00004.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.