CM-AT: Single unit does powder of active substance (CM-AT) administered 3 times per day
Study 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.
Eligibility
Sex
ALL
Min age
3 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
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.
Trial sites (31)
Facility
City
Region
Status
Southwest Autism Research & Resource Center (S.A.R.R.C.)
Phoenix
Arizona
University of Arizona, Pediatrics Multidisciplinary Research Unit
Tucson
Arizona
Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)
Little Rock
Arkansas
N.R.C. Research Institute
Orange
California
M.I.N.D. Institute (Univ.of California, Davis)
Sacramento
California
University of California (U.C.S.F.)
San Francisco
California
IMMUNOe Research Centers
Centennial
Colorado
Yale Child Study Center
New Haven
Connecticut
Segal Institute For Clinical Research
North Miami
Florida
Advent Health -Lake Mary Pediatrics
Orange City
Florida
A.P.G. Research
Orlando
Florida
Research Institute of Deaconess Clinic
Newburgh
Indiana
Lake Charles Clinical Trials
Lake Charles
Louisiana
L.S.U. Health Sciences Center
Shreveport
Louisiana
Detroit Clinical Research Center, P.C.
Bingham Farms
Michigan
Children'S Specialized Hospital
Egg Harbor
New Jersey
Children's Specialized Hospital
Toms River
New Jersey
Clinical Research Center of Nj
Voorhees Township
New Jersey
Lovelace Scientific Resources
Albuquerque
New Mexico
Richmond Behavioral Associates
Staten Island
New York
Montefiore Med.Cneter, Autism & Obsessive Compulsive Spectrum Program
The Bronx
New York
Duke Center For Autism and Brain Development
Durham
North Carolina
Cleveland Clinic Autism Center
Cleveland
Ohio
Omega Medical Research
Warwick
Rhode Island
Carolina Clinical Trials, Inc.
Charleston
South Carolina
Vanderbilt Universtiy Med.Center-Treatment&Research Inst. For Asd
Nashville
Tennessee
University of Texas, Houston-Behavioral & Biomedical Sciences
Houston
Texas
Focus Center of Clinical Research
Clinton
Utah
University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences
Charlottesville
Virginia
Neuroscience, Inc
Herndon
Virginia
Carilion Clinic-Virginia Tech, Carilion School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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