Trial record 5 of 180 for:
autism | Open Studies
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:
Curemark
Information provided by (Responsible Party):
Curemark
ClinicalTrials.gov Identifier:
NCT00912691
First received: June 2, 2009
Last updated: April 17, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 June 17, 2013