Trials / Active Not Recruiting
Active Not RecruitingNCT02649959
An Open Label Study of CM-AT for the Treatment of Children With Autism
An Open-Label Extension Study of CM-AT for the Treatment of Children With Autism With All Levels of Fecal Chymotrypsin
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 405 (estimated)
- Sponsor
- Curemark · Industry
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CM-AT | Single unit does powder of active substance (CM-AT) administered 3 times per day |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2028-01-01
- Completion
- 2028-01-01
- First posted
- 2016-01-08
- Last updated
- 2026-03-18
Locations
31 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02649959. Inclusion in this directory is not an endorsement.