Trials / Completed
CompletedNCT00881452
A Trial of CM-AT in Children With Autism
A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 182 (actual)
- Sponsor
- Curemark · Industry
- Sex
- All
- Age
- 3 Years – 8 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.
Detailed description
Autism is currently a significant cause of disability in the pediatric population. Treatment is based upon the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a powder taken three times a day.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CM-AT | Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days |
| DRUG | Placebo | Single unit dose powder of non-active substance administered 3 times per day for 90 days |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2011-06-01
- Completion
- 2011-09-01
- First posted
- 2009-04-15
- Last updated
- 2018-04-19
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00881452. Inclusion in this directory is not an endorsement.