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



Status:Recruiting
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:3 - 8
Updated:1/25/2017
Start Date:October 2015
End Date:October 2018
Contact:Kristin M Walsh, RN, MSN
Email:clinical@curemark.com
Phone:914-925-3697

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

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.

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.

Inclusion Criteria:

- Ongoing 00104 Protocol required completion of 00103 Protocol

- Currently in the 00102 open label study and continues to meet eligibility
requirements

- Subjects (approximately 60) who initially qualified for 00103 screening, who
subsequently failed baseline entrance criteria for randomization (@Visit 1) baseline
assessment of the ABC eligibility requirement

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.
We found this trial at
33
sites
Orange, California 92868
Principal Investigator: Tony Ortiz, PhD
Phone: 714-289-1100
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
Principal Investigator: Richard Ohnmacht, MD
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Warwick, RI
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Albuquerque, New Mexico 87108
Principal Investigator: Jeffrey Lewine, PhD
Phone: 505-348-9500
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Bingham Farms, Michigan 48334
Principal Investigator: Edward Dabrowski, MD
Phone: 248-716-7009
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Bronx, New York 10467
Principal Investigator: Eric Hollander, MD
Phone: 718-920-6483
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Centennial, Colorado 80112
Principal Investigator: Isaac Melamed, MD
Phone: 303-771-9000
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Centennial, CO
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Charleston, South Carolina 29405
Principal Investigator: Steven G. Lopez, MD
Phone: 843-576-6750
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Charlottesville, Virginia 22903
Phone: 434-243-3678
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Cleveland, Ohio 44104
Principal Investigator: Thomas Frazier, PhD
Phone: 216-448-6682
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Cleveland, OH
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Clinton, Utah 84015
Principal Investigator: Samantha Bostrom, MD
Phone: 801-614-5522
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Clinton, UT
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Durham, North Carolina 27705
Principal Investigator: Lin Sikich, MD
Phone: 919-681-0041
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6106 East Black Horse Pike
Egg Harbor Township, New Jersey 08234
Principal Investigator: Yvette Janvier, MD
Phone: 732-914-1100
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Herndon, Virginia 20170
Principal Investigator: Keith Saylor, PhD, ScM
Phone: 703-787-9090
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Houston, Texas 77054
Principal Investigator: Deborah Pearson, PhD
Phone: 713-486-2591
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Lake Charles, Louisiana 70601
Principal Investigator: Kashinath G. Yadalam, MD
Phone: 337-564-6405
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Little Rock, Arkansas 72202
Principal Investigator: Richard Frye, MD
Phone: 501-364-3556
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Nashville, Tennessee 37232
Principal Investigator: Kevin B Sanders, MD
Phone: 615-936-3288
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New Haven, Connecticut 06520
Principal Investigator: Roger J Jou, MD, MPH, PhD
Phone: 203-927-3970
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Newburgh, Indiana 47630
Principal Investigator: Michelle Galen, MD
Phone: 812-490-4505
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North Miami, Florida 33161
Principal Investigator: Scott Segal, MD
Phone: 305-722-8444
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2505 Junior Street
Orange City, Florida 32763
Principal Investigator: Miles Landis, MD
Phone: 386-960-8282
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Orlando, Florida 32803
Principal Investigator: Morteza Nadjafi, MD
Phone: 407-423-7149
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Phoenix, Arizona
Principal Investigator: Raun Melmed, MD
Phone: 602-218-8225
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Roanoke, Virginia 24014
Principal Investigator: Anita Kablinger, MD
Phone: 540-981-8829
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Sacramento, California 95817
Principal Investigator: Randi Hagerman, MD
Phone: 916-703-0247
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San Francisco, California 94131
Principal Investigator: Robert Hendren, DO
Phone: 415-476-7803
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Shreveport, Louisiana
Principal Investigator: Rita Horton, MD
Phone: 318-813-2070
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Staten Island, New York 10312
Principal Investigator: Mark DiBuono, MD
Phone: 718-227-1897
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3260 East 104th Avenue
Thornton, Colorado 80233
Principal Investigator: Isaac Melemed, MD
Phone: 303-771-9000
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2142 North Cove Boulevard
Toledo, Ohio 43606
Principal Investigator: Jeffrey Blumer, PhD, MD
Phone: 419-291-2757
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Tom's River, New Jersey 08755
Principal Investigator: Yvette Janvier, MD
Phone: 732-914-1100
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Tucson, Arizona 85724
Principal Investigator: Sydney Rice, MD, MSc
Phone: 520-626-1994
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Voorhees, New Jersey 08043
Principal Investigator: Mark Mintz, MD
Phone: 856-784-1899
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