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CM-AT for Autism

Phase 3

Waitlist Available

Led By Deborah Pearson, PhD

Research Sponsored by Curemark

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R

Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in Sponsor 00103 Study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to each post-baseline visit, through study completion week 72.

Awards & highlights

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.

Who is the study for?

This trial is for children with autism aged 3-8 who participated in a prior study (Sponsor's 00103 Study) or are currently in the open label study (00102). It also includes new participants aged 9-17 meeting DSM-IV-TR criteria for Autistic Disorder. Exclusions include severe head trauma, allergy to porcine products, SSRI use without stable dosing, significant systemic disease, dietary restrictions except nut allergies and lactose-free diets, weight under 13kg, trypsin sensitivities/allergies, ADHD medication use within five days of starting the trial.Check my eligibility

What is being tested?

The clinical trial is testing CM-AT on pediatric patients with autism to evaluate its safety and effectiveness over time. This Phase III trial allows all levels of fecal chymotrypsin among participants and does not involve a control group as it is an open-label extension study.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions due to porcine product ingredients in CM-AT. Participants should be monitored for any adverse effects related to digestive enzymes present in the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 9-17 years old and have been diagnosed with Autism.

Select...

I am between 3 and 8 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to each post-baseline visit, through study completion week 72.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to each post-baseline visit, through study completion week 72.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to each post-baseline visit, through study completion week 72. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aberrant Behavioral Checklist: Subscale of Irritability / Agitation (ABC-I) at fecal chymotrypsin (FCT) levels less than or equal to 12.6

Secondary outcome measures

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

Side effects data

From 2017 Phase 3 trial • 190 Patients • NCT02410902

26%

Nasopharyngitis

18%

Constipation

16%

Pyrexia

16%

Stool pH Decreased

12%

Vomiting

12%

Upper Respiratory Tract Infections

11%

Oropharyngeal Pain

Ear Pain

Clostridium Test Positive

Cough

Seasonal Allergy

Diarrhoea

Headache

Rash

Stool pH Increased

Stool Analysis Abnormal

100%

80%

60%

40%

20%

Study treatment Arm

CM-AT

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open LabelExperimental Treatment1 Intervention

CM-AT

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CM-AT

2010

Completed Phase 3

~540

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

CuremarkLead Sponsor

3 Previous Clinical Trials

537 Total Patients Enrolled

Deborah Pearson, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

1 Previous Clinical Trials

190 Total Patients Enrolled

Robert Hendren, DOPrincipal InvestigatorUniversity of California, San Francisco

4 Previous Clinical Trials

245 Total Patients Enrolled

2 Trials studying Autism Spectrum Disorder

34 Patients Enrolled for Autism Spectrum Disorder

Media Library

CM-AT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02649959 — Phase 3

Autism Spectrum Disorder Research Study Groups: Open Label

Autism Spectrum Disorder Clinical Trial 2023: CM-AT Highlights & Side Effects. Trial Name: NCT02649959 — Phase 3

CM-AT (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649959 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For this particular test, is the age limit over 50 years old?

"The age bracket for participants in this study is 3 years to 17 years old."

Answered by AI

How do I sign up for the clinical trial?

"In order to be qualified for this study, potential participants must be 3 to 17 years old and have a diagnosis of autistic disorder. Additionally, they must have failed the Baseline entrance criteria for randomization, met the eligibility requirements for the Sponsor's 00103 Study, and completed the study."

Answered by AI

Are there many test sites for this experiment located throughout the United States?

"The primary locations for this clinical trial are Yale Child Study Center in New Haven, Connecticut, University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences in Charlottesville, Virginia, and Children'S Specialized Hospital in Egg Harbor Township, New jersey. Additionally, there are 31 other active trial sites."

Answered by AI

Are there any open positions left in this clinical trial?

"This particular trial, as indicated by clinicaltrials.gov, is not presently looking for participants. It was initially posted on October 1st, 2015 but was most recently updated on August 2nd, 2022. Although not recruiting at this time, there are 206 other trials that are."

Answered by AI