An Open Label Study of CM-AT for the Treatment of Children With Autism
Purpose
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.
Condition
- Autism
Eligibility
- Eligible Ages
- Between 3 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open Label |
CM-AT |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Curemark
Study Contact
Detailed 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.