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A Trial of CM-AT in Children With Autism- Open Label Extension Study (CM-AT)

Primary Purpose

Autism

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CM-AT
Sponsored by
Curemark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)
  • Ongoing 00102 Protocol required completion of 00101 Protocol
  • Now recruiting subjects directly into 00102 Protocol

Exclusion Criteria:

  • Ongoing study required patients to be 3-8 years old weighing < 11kg (24.2 lbs.), and achieving ages 9-12 years old weighing < 22kg (48.4 lbs.).
  • Newly recruited subjects must be between ages 9 - 12 years old weighing < 22kgs (48.4 lbs.)
  • Demonstrated previous allergy to porcine (pork) products
  • Previous history of severe head trauma or stroke, seizure within one year of entering study or uncontrolled systemic disease
  • Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease
  • Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion)
  • Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance

Sites / Locations

  • Southwest Autism Research and Resource Center
  • University of California, Davis, M.I.N.D. Institute
  • University of California, San Francisco
  • Neuropsychiatric Research Center of Orange County
  • Lake Mary Pediatrics
  • Institute for Behavioral Medicine
  • Alexian Brothers Center for Psychiatric Research
  • Louisiana State University
  • Saint Peter's University Hospital
  • Mount Sinai School of Medicine
  • University of North Carolina, Chapel Hill
  • Ohio State University
  • Oklahoma State University, Child Study Center
  • Cyn3rgy Research Center
  • Hershey Medical Center
  • Drexel University
  • Universtiy of Pittsburgh
  • University of Texas, Houston
  • Ericksen Research & Development

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

CM-AT

Outcomes

Primary Outcome Measures

Evidence of changes in behavior scales associated with the core symptoms of autism

Secondary Outcome Measures

Other key measures of behavior and quality of life associated with autism

Full Information

First Posted
June 2, 2009
Last Updated
February 26, 2019
Sponsor
Curemark
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1. Study Identification

Unique Protocol Identification Number
NCT00912691
Brief Title
A Trial of CM-AT in Children With Autism- Open Label Extension Study
Acronym
CM-AT
Official Title
A Phase III Open Label Extension Study of CM-AT in Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Curemark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.
Detailed Description
Autism is currently a significant cause of disability in the pediatric population. CM-AT 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. It is formulated to be released in the small intestine to enhance protein digestion thus increasing the availability of essential amino acids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CM-AT
Intervention Type
Drug
Intervention Name(s)
CM-AT
Intervention Description
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Primary Outcome Measure Information:
Title
Evidence of changes in behavior scales associated with the core symptoms of autism
Time Frame
Baseline, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks
Secondary Outcome Measure Information:
Title
Other key measures of behavior and quality of life associated with autism
Time Frame
Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD) Ongoing 00102 Protocol required completion of 00101 Protocol Now recruiting subjects directly into 00102 Protocol Exclusion Criteria: Ongoing study required patients to be 3-8 years old weighing < 11kg (24.2 lbs.), and achieving ages 9-12 years old weighing < 22kg (48.4 lbs.). Newly recruited subjects must be between ages 9 - 12 years old weighing < 22kgs (48.4 lbs.) Demonstrated previous allergy to porcine (pork) products Previous history of severe head trauma or stroke, seizure within one year of entering study or uncontrolled systemic disease Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion) Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Arnold, MD
Organizational Affiliation
Ohio State University, Nisonger Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Autism Research and Resource Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California, Davis, M.I.N.D. Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Lake Mary Pediatrics
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Institute for Behavioral Medicine
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Louisiana State University
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Mount Sinai School of Medicine
City
Manhattan
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma State University, Child Study Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Name
Cyn3rgy Research Center
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Universtiy of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
University of Texas, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Ericksen Research & Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States

12. IPD Sharing Statement

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A Trial of CM-AT in Children With Autism- Open Label Extension Study

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