At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 190 enrolled
Drug / intervention
CM-AT +1 moredrug
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.
A Double Blind, Randomized, Placebo-Controlled Study of CM-AT for the Treatment of Autism in Children With All Levels of Fecal Chymotrypsin (FCT)
In Brief
A Phase 3 clinical trial evaluating CM-AT and PLACEBO for Autism. Completed, enrolled 190 participants across 31 sites.
Detailed Summary
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartMay 2015
Primary CompletionDec 2017
TodayJul 2026
First PostedApr 8, 2015
Enrollment StartMay 13, 2015
Primary CompletionDec 22, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.2 years ago
Interventions
CM-ATdrug
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
PLACEBOdrug
Single unit dose powder of non-active substance administered 3 times per day for 90 days