At a glance
ClinicalIndex Comparison RecordPhase 3Active· 405 target
Drug / intervention
CM-ATdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Extension Study of CM-AT for the Treatment of Children With Autism With All Levels of Fecal Chymotrypsin
In Brief
A Phase 3 clinical trial evaluating CM-AT for Autism. Active but no longer recruiting, targeting 405 participants across 31 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
Collaborators--
Timeline
Phase 3Active
2016201720182019202020212022202320242025202620272028
Enrollment StartOct 2015
First PostedJan 2016
TodayJul 2026
Primary CompletionJan 2028
First PostedJan 8, 2016
Enrollment StartOct 1, 2015
Primary CompletionJan 1, 2028
TodayJul 2, 2026
Enrollment to primary: 12.3 yearsPosted 10.5 years agoPrimary completion in 1.5 years
Interventions
CM-ATdrug
Single unit does powder of active substance (CM-AT) administered 3 times per day