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

Curemark

Status and phase

Active, not recruiting

Phase 3

Conditions

Autism

Treatments

Drug: CM-AT

Study type

Interventional

Funder types

Industry

Identifiers

NCT02649959

00104/Open Label-Autism

Details and patient eligibility

About

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.

Full description

Autism is clearly a significant cause of disability in the pediatric population. Treatment is based on the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.

Enrollment

405 estimated patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

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.