blüm: The Study of a Biological Autism Medication

This study is sponsored by Curemark, LLC

Investigators at the Duke Center for Autism and Brain Development are studying an investigational drug in children ages 3-8 with autism.  The investigational drug, CM-AT is an enzyme that is sprinkled over food three times a day that aims to improve digestion of protein and reduce harmful gut/brain interactions and therefore may improve symptoms associated with autism.

Specifically, investigators want to see if the study drug may help improve symptoms such as irritability. Researchers will evaluate children using psychological, psychiatric, medical, behavioral, and developmental measures. Children who meet eligibility criteria will have the opportunity to enroll in a 12-week clinical trial in which they will receive a powdered investigational drug or a placebo (a powder containing no active drug). This 12-week trial will be followed by an open-label trial so all eligible participants may receive investigational drug. This investigational drug is not approved by the United States Food and Drug Administration.

The study involves in person visits every two weeks for the duration of the study at our center. Participants will be provided with parking. Research related services and medication will be provided at no cost. Participants will be compensated for travel.

For more information call 1-888-691-1062 or email autismresearch@duke.edu

IRB Number: Pro00064746

Click here to download a study brochure.

 

Criteria
Children ages 3-8 with a diagnosis or suspected diagnosis of autism.
Enrollment status
Completed