CM-AT for Autistic Disorder

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Autistic Disorder+1 More
CM-AT - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a drug called CM-AT to see if it is safe and effective in treating children with autism who have all levels of fecal chymotrypsin.

Eligible Conditions
  • Autistic Disorder
  • Autism, Early Infantile

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Change from Baseline to each post-baseline visit, through study completion Week 72.

Week 72
Aberrant Behavior Checklist: Subscale of Lethargy / Social Withdrawal (ABC-L) at fecal chymotrypsin (FCT) levels less than or equal to 12.6
Aberrant Behavioral Checklist: Subscale of Irritability / Agitation (ABC-I) at fecal chymotrypsin (FCT) levels less than or equal to 12.6

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

CM-AT
26%Nasopharyngitis
18%Constipation
16%Pyrexia
16%Stool pH Decreased
12%Upper Respiratory Tract Infections
12%Vomiting
11%Oropharyngeal Pain
9%Ear Pain
8%Cough
8%Clostridium Test Positive
5%Seasonal Allergy
5%Diarrhoea
4%Headache
4%Stool pH Increased
4%Rash
3%Stool Analysis Abnormal
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02410902) in the CM-AT ARM group. Side effects include: Nasopharyngitis with 26%, Constipation with 18%, Pyrexia with 16%, Stool pH Decreased with 16%, Upper Respiratory Tract Infections with 12%.

Trial Design

1 Treatment Group

Open Label
1 of 1

Experimental Treatment

405 Total Participants · 1 Treatment Group

Primary Treatment: CM-AT · No Placebo Group · Phase 3

Open Label
Drug
Experimental Group · 1 Intervention: CM-AT · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CM-AT
2010
Completed Phase 3
~540

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to each post-baseline visit, through study completion week 72.

Who is running the clinical trial?

CuremarkLead Sponsor
3 Previous Clinical Trials
537 Total Patients Enrolled
3 Trials studying Autistic Disorder
537 Patients Enrolled for Autistic Disorder
Deborah Pearson, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
190 Total Patients Enrolled
1 Trials studying Autistic Disorder
190 Patients Enrolled for Autistic Disorder
Robert Hendren, DOPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
249 Total Patients Enrolled
3 Trials studying Autistic Disorder
229 Patients Enrolled for Autistic Disorder

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
will be allowed to continue in the study Subjects who initially qualified for 00103 screening, but did not meet Baseline entrance criteria for randomization (@Visit 1), will be allowed to continue in the study if they continue to meet eligibility requirements.
, and who have not had a previous comprehensive behavior intervention program, will be randomly assigned to receive 24 weeks of ABA Services or Community Treatment
People who are 3 to 8 years old, inclusive, can participate in the Sponsor 00103 Study
Participants in the Sponsor's 00103 study who continue to meet eligibility requirements will be contacted again at a future date to assess their long-term safety and efficacy.
We are currently studying this drug in a group of people and continue to enroll those who meet the eligibility requirements.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Michigan100.0%
How old are they?
< 18100.0%
What site did they apply to?
Detroit Clinical Research Center, P.C.100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References