An Open Label Study of CM-AT for the Treatment of Children With Autism

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Curemark

Criteria

Inclusion Criteria:

• Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in Sponsor 00103 Study

• Completion of the Sponsor's 00103 Study who continue to meet eligibility requirements

• Currently in the 00102 open label study and continue to meet eligibility requirements

• Subjects who initially qualified for 00103 screening, who subsequently failed Baseline entrance criteria for randomization (@Visit 1) Baseline assessment of the ABC eligibility requirement who continue to meet eligibility requirements

• Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R

Exclusion Criteria:

• Patient weighing < 13kg

• Allergy to porcine products

• Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase

• History of severe head trauma, as defined by loss of consciousness or hospitalization, skull fracture or stroke.

• Seizure within the last year prior to enrollment, or the need for seizure medications either at present or in the past.

• Evidence or history of severe, moderate or uncontrolled systemic disease

• Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose free is allowable but not dairy free.

• Inability to ingest the study drug / non-compliance with dosing schedule.

• Inability to follow the prescribed dosing schedule.

• Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to the initial randomized study period.

• Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days prior to entering the study.

• History of premature birth <35 weeks gestation.

• Prior history of stroke in utero or other in utero insult.