Trial record 11 of 472 for:    "Autism"

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

This study is currently recruiting participants.
Verified April 2013 by Curemark
Sponsor:
Information provided by (Responsible Party):
Curemark
ClinicalTrials.gov Identifier:
NCT00912691
First received: June 2, 2009
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.


Condition Intervention Phase
Autism
Drug: CM-AT
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Open Label Extension Study of CM-AT in Children With Autism

Resource links provided by NLM:


Further study details as provided by Curemark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CM-AT
Drug: CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

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.

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912691

Locations
United States, Arizona
Southwest Autism Research and Resource Center Recruiting
Phoenix, Arizona, United States, 85006
Contact: Amanda Akdere, CRC    480-603-3285    AAkdere@autismcenter.org   
Principal Investigator: Raun Melmed, MD         
United States, California
University of California, Davis, M.I.N.D. Institute Completed
Sacramento, California, United States, 95817
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Felicia Widjaja, MPH    415-476-7803    FelFelicia.Widjaja@ucsf.edu   
Principal Investigator: Robert Hendren, DO         
Neuropsychiatric Research Center of Orange County Completed
Santa Ana, California, United States, 92701
United States, Florida
Lake Mary Pediatrics Recruiting
Orange City, Florida, United States, 32763
Contact: Heidi Andersen, RN    386-960-8282      
Principal Investigator: Miles Landis, MD         
United States, Georgia
Institute for Behavioral Medicine Completed
Symrna, Georgia, United States, 30080
United States, Illinois
Alexian Brothers Center for Psychiatric Research Completed
Hoffman Estates,, Illinois, United States, 60169
United States, Louisiana
Louisiana State University Active, not recruiting
Shreveport, Louisiana, United States, 71103
United States, New Jersey
Saint Peter's University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Mount Sinai School of Medicine Completed
Manhattan, New York, United States, 10029
United States, North Carolina
University of North Carolina, Chapel Hill Completed
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Ohio State University Active, not recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma State University, Child Study Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
Cyn3rgy Research Center Completed
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Hershey Medical Center Completed
Hershey, Pennsylvania, United States, 17033
Drexel University Completed
Philadelphia, Pennsylvania, United States, 19124
Universtiy of Pittsburgh Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15260
United States, Texas
University of Texas, Houston Recruiting
Houston, Texas, United States, 77054
Contact: Rosleen Mansour, MA    713-486-2591    Rosleen.Mansour@uth.tmc.edu   
Principal Investigator: Deborah Pearson, PhD         
United States, Utah
Ericksen Research & Development Recruiting
Clinton, Utah, United States, 84015
Contact: Jerika Stewart, CCRP    801-614-5505    jstewart@westsidemedical.org   
Principal Investigator: Samantha Bostrom, MD         
Sponsors and Collaborators
Curemark
Investigators
Principal Investigator: Eugene Arnold, MD Ohio State University, Nisonger Center
  More Information

No publications provided

Responsible Party: Curemark
ClinicalTrials.gov Identifier: NCT00912691     History of Changes
Other Study ID Numbers: 00102/Autism
Study First Received: June 2, 2009
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Curemark:
Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014