Clinical Trial Details

Overview

Research Study Summary

A Double-Blind, Randomized, Placebo Controlled Study of CM_AT for the Treatment of Autism in Children 3-8 Years Old. (The Blüm Study)

Purpose

Autism is clearly a significant cause of disability in the pediatric population. Many children with Autism exhibit impaired protein digestion which may or may not manifest in self-restricted diets. The inability to digest protein affects the availability of essential amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine.

CM-AT is a proprietary enzyme that is designed as a granulated powder to be taken three times daily.

Watch this video to learn more about the Blüm Study, the clinical trial of CM-AT, an investigational new drug, for the treatment of Autism in children 3-8 years of age.

The Blüm Study

(386) 960-8282 ext 6

To Learn more

CW ID: 212102
Date Last Changed: May 31, 2016

Clinical Trial Snapshot

Gender
Both Male and Female
Age
3 to 8 Years
Overall Status
Recruiting
Facility Type
N/A

Eligibility

Ages Eligible for Study: 3 Years to 8 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: Yes

Inclusion Criteria:

  • Meets the current Diagnostic and Statistical Manual with Mental Disorders (DSM-IV-TR) for Autism (Autistic Disorder), screened by SCQ and confirmed by ADI-R

Exclusion Criteria:

  • Patient weighing < 13kg (28.6 lbs)
  • Previous allergy to porcine (pork) products
  • Previous history of severe head trauma or stroke, loss of consciousness, seizure (or need for seizure medication either present or past) within one year of entering study or uncontrolled systemic disease
  • Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease, muscular dystrophy, known genetic disorder, blood dyscrasia, ongoing GI disease
  • Evidence of severe, moderate or uncontrolled systemic disease; and/or any co-morbid condition which in the Investigator's or Medical Director's opinion makes it undesirable for the subject to participate in the study or jeopardizes compliance with the protocol
  • Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion)
  • Ongoing dietary restriction for allergy or other reasons except nut allergies (lactose-free allowable)
  • Use of of any stimulant medication must be discontinued 5 days prior to entering the study
  • Subject must have a stable dose of SSRI's for at least 30 days
  • Inability to ingest study drug and/or follow prescribed dosing schedule

Contact

(386) 960-8282 ext 6

Heidi Andersen
Lake Mary Pediatrics
2505 Junior Street
Orange City, FL 32763

View Map

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.