Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT02410902
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
8 Years
Study:
NCT02410902
Study Brief:
Protocol Section:
NCT02410902