A Trial of CM-AT in Children With Autism- Open Label Extension Study



Status:Completed
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:9 - 12
Updated:3/18/2017
Start Date:January 2010
End Date:February 2016

Use our guide to learn which trials are right for you!

A Phase III Open Label Extension Study of CM-AT in Children With Autism

The purpose of this study is to determine whether CM-AT is effective in treating the core
symptoms of autism.

Autism is currently a significant cause of disability in the pediatric population. CM-AT is
based upon the observation that many children with autism do not digest protein. CM-AT is a
proprietary enzyme that is designed as a powder taken three times a day. It is formulated to
be released in the small intestine to enhance protein digestion thus increasing the
availability of essential amino acids.

Inclusion Criteria:

- Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR)
diagnostic criteria for autistic disorder (AD)

- Ongoing 00102 Protocol required completion of 00101 Protocol

- Now recruiting subjects directly into 00102 Protocol

Exclusion Criteria:

- Ongoing study required patients to be 3-8 years old weighing < 11kg (24.2 lbs.), and
achieving ages 9-12 years old weighing < 22kg (48.4 lbs.).

- Newly recruited subjects must be between ages 9 - 12 years old weighing < 22kgs (48.4
lbs.)

- 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)

- Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for
30 days prior to entrance
We found this trial at
19
sites
Hoffman Estates, Illinois 60169
?
mi
from
Hoffman Estates, IL
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Gresham, Oregon 97030
?
mi
from
Gresham, OR
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Manhattan, New York 10029
?
mi
from
Manhattan, NY
Click here to add this to my saved trials
254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73117
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange City, Florida 32763
?
mi
from
Orange City, FL
Click here to add this to my saved trials
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15260
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Shreveport, Louisiana 71103
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Symrna, Georgia 30080
?
mi
from
Symrna, GA
Click here to add this to my saved trials