A Phase III Randomized Double Blind Placebo Controlled Trial of LUMINENZ-AT™ (CM-AT) In Children with Autism

Focus of Study:

The study focuses on children, ages 3-8, diagnosed with autistic disorder, who are willing to take an investigational medication, Luminenz-AT, or a placebo for 3 months.

Purpose:

The purpose of this research study is to examine the safety and efficacy of an investigational medication on irritability associated with autistic disorder. This is a 3 month research study where participants will either receive placebo or the active enzyme in the form of sprinkles to be placed on food. Participants will be expected to come in for up to 6 office visits that last up to 3 hours each. Stool samples will also be collected at home over the course of the study.

Subjects will be reimbursed for travel expenses incurred for each office visit during the study. Outpatient care during study-related visits and diagnostic and developmental evaluations will be provided at no cost. Parking coupons will be provided and the investigational medication is supplied by the sponsor, Curemark, LLC.

Enrollment:

20 subjects are expected to participate at UNC (170 total and between 10-14 other sites)

Primary Completion Date:

TBD

Ages of Eligibility:

3-8

Inclusion Criteria:

be between 3 and 8 years old, male or female, of any ethnicity
meet criteria for a diagnosis of autism based on the DSM-IV-TR, Autism Diagnostic Interview-Revised, and Social Communication Questionnaire
have a parent or guardian who is able and willing to give written informed consent
if competent and at least 7 years old, give written assent for their own participation

Exclusion Criteria:

epilepsy or another significant chronic medical illness
is on specific dietary restrictions (except for nut allergies)

Contacts:

Contact person: Lindsey Hazzard

Phone: 1-800-708-0048

E-mail: aspire@unc.edu

Website: www.aspire.unc.edu

Locations:

UNC Neurosciences Hospital DNC clinic

Sponsors & Collaborators:

Drug supplied by manufacturer, Curemark, LLC

Investigators:

PI: Linmarie Sikich, MD