An Open Label Study of CM-AT for the Treatment of Children With Autism

Autism Clinical Trial

Official title:

An Open-Label Extension Study of CM-AT for the Treatment of Children With Autism With All Levels of Fecal Chymotrypsin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02649959
• Other study ID #: 00104/Open Label-Autism
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Curemark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 405
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Drug:
• CM-AT
Single unit does powder of active substance (CM-AT) administered 3 times per day

Locations

Country	Name	City	State
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Detroit Clinical Research Center, P.C.	Bingham Farms	Michigan
United States	Montefiore Med.Cneter, Autism & Obsessive Compulsive Spectrum Program	Bronx	New York
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences	Charlottesville	Virginia
United States	Cleveland Clinic Autism Center	Cleveland	Ohio
United States	Focus Center of Clinical Research	Clinton	Utah
United States	Duke Center For Autism and Brain Development	Durham	North Carolina
United States	Children'S Specialized Hospital	Egg Harbor Township	New Jersey
United States	Neuroscience, Inc	Herndon	Virginia
United States	University of Texas, Houston-Behavioral & Biomedical Sciences	Houston	Texas
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)	Little Rock	Arkansas
United States	Vanderbilt Universtiy Med.Center-Treatment&Research Inst. For Asd	Nashville	Tennessee
United States	Yale Child Study Center	New Haven	Connecticut
United States	Research Institute of Deaconess Clinic	Newburgh	Indiana
United States	Segal Institute For Clinical Research	North Miami	Florida
United States	N.R.C. Research Institute	Orange	California
United States	Advent Health -Lake Mary Pediatrics	Orange City	Florida
United States	A.P.G. Research	Orlando	Florida
United States	Southwest Autism Research & Resource Center (S.A.R.R.C.)	Phoenix	Arizona
United States	Carilion Clinic-Virginia Tech, Carilion School of Medicine	Roanoke	Virginia
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	L.S.U. Health Sciences Center	Shreveport	Louisiana
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Barbara Enright	Toms River	New Jersey
United States	University of Arizona, Pediatrics Multidisciplinary Research Unit	Tucson	Arizona
United States	Clinical Research Center of Nj	Voorhees	New Jersey
United States	Omega Medical Research	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Curemark

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.