Phase 3
N=190
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
Autism
Bottom Line
View on ClinicalTrials.gov: NCT02410902 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Primary Outcome Measurements to Determine Efficacy of Treatment With CM-AT Versus Placebo for Changes in the Aberrant Behavior Checklist Subscale for Irritability / Agitation (ABC-I) Between Baseline and Week 12/Termination Visit — -8.0; -5.5 units on a scale — p=0.038
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CM-AT (Drug); PLACEBO (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Curemark
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome Measurements to Determine Efficacy of Treatment With CM-AT Versus Placebo for Changes in the Aberrant Behavior Checklist Subscale for Irritability / Agitation (ABC-I) Between Baseline and Week 12/Termination Visit |
-8.0; -5.5 | 0.038 sig |
| SECONDARY Secondary Outcome Measurements of Changes in the Aberrant Behavior Checklist Checklist Subscale for Lethargy / Social Withdrawal (ABC-L) Between Baseline and Week 12/Termination Visit |
-7.9; -6.6 | 0.325 |
Summary
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.
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
Data sourced from ClinicalTrials.gov (NCT02410902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.