An Open Label Study of CM-AT for the Treatment of Children With Autism
- Registration Number
- NCT02649959
- Lead Sponsor
- Curemark
- Brief Summary
This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.
- Detailed Description
Autism is clearly a significant cause of disability in the pediatric population. Treatment is based on the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 405
- Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in Sponsor 00103 Study
- Completion of the Sponsor's 00103 Study who continue to meet eligibility requirements
- Currently in the 00102 open label study and continue to meet eligibility requirements
- Subjects who initially qualified for 00103 screening, who subsequently failed Baseline entrance criteria for randomization (@Visit 1) Baseline assessment of the ABC eligibility requirement who continue to meet eligibility requirements
- Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R
- Patient weighing < 13kg
- Allergy to porcine products
- Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase
- History of severe head trauma, as defined by loss of consciousness or hospitalization, skull fracture or stroke.
- Seizure within the last year prior to enrollment, or the need for seizure medications either at present or in the past.
- Evidence or history of severe, moderate or uncontrolled systemic disease
- Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose free is allowable but not dairy free.
- Inability to ingest the study drug / non-compliance with dosing schedule.
- Inability to follow the prescribed dosing schedule.
- Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to the initial randomized study period.
- Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days prior to entering the study.
- History of premature birth <35 weeks gestation.
- Prior history of stroke in utero or other in utero insult.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label CM-AT CM-AT
- Primary Outcome Measures
Name Time Method Aberrant Behavioral Checklist: Subscale of Irritability / Agitation (ABC-I) at fecal chymotrypsin (FCT) levels less than or equal to 12.6 Change from Baseline to each post-baseline visit, through study completion Week 72.
- Secondary Outcome Measures
Name Time Method Aberrant Behavior Checklist: Subscale of Lethargy / Social Withdrawal (ABC-L) at fecal chymotrypsin (FCT) levels less than or equal to 12.6 Change from Baseline to each post-baseline visit, through study completion Week 72.
Trial Locations
- Locations (31)
Southwest Autism Research & Resource Center (S.A.R.R.C.)
🇺🇸Phoenix, Arizona, United States
University of Arizona, Pediatrics Multidisciplinary Research Unit
🇺🇸Tucson, Arizona, United States
Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)
🇺🇸Little Rock, Arkansas, United States
N.R.C. Research Institute
🇺🇸Orange, California, United States
M.I.N.D. Institute (Univ.of California, Davis)
🇺🇸Sacramento, California, United States
University of California (U.C.S.F.)
🇺🇸San Francisco, California, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Yale Child Study Center
🇺🇸New Haven, Connecticut, United States
Segal Institute For Clinical Research
🇺🇸North Miami, Florida, United States
Advent Health -Lake Mary Pediatrics
🇺🇸Orange City, Florida, United States
A.P.G. Research
🇺🇸Orlando, Florida, United States
Research Institute of Deaconess Clinic
🇺🇸Newburgh, Indiana, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
L.S.U. Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Detroit Clinical Research Center, P.C.
🇺🇸Bingham Farms, Michigan, United States
Children'S Specialized Hospital
🇺🇸Egg Harbor Township, New Jersey, United States
Children's Specialized Hospital
🇺🇸Toms River, New Jersey, United States
Clinical Research Center of Nj
🇺🇸Voorhees, New Jersey, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
Montefiore Med.Cneter, Autism & Obsessive Compulsive Spectrum Program
🇺🇸Bronx, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Duke Center For Autism and Brain Development
🇺🇸Durham, North Carolina, United States
Cleveland Clinic Autism Center
🇺🇸Cleveland, Ohio, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Carolina Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
Vanderbilt Universtiy Med.Center-Treatment&Research Inst. For Asd
🇺🇸Nashville, Tennessee, United States
University of Texas, Houston-Behavioral & Biomedical Sciences
🇺🇸Houston, Texas, United States
Focus Center of Clinical Research
🇺🇸Clinton, Utah, United States
University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences
🇺🇸Charlottesville, Virginia, United States
Neuroscience, Inc
🇺🇸Herndon, Virginia, United States
Carilion Clinic-Virginia Tech, Carilion School of Medicine
🇺🇸Roanoke, Virginia, United States