Clinical trial NCT00912691: A Trial of CM-AT in Children With Autism- Open Label Extension Study
Official title: A Phase III Open Label Extension Study of CM-AT in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism
Keywords: Autism
Lead sponsor: Curemark
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 165
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evidence of changes in behavior scales associated with the core symptoms of autism
timeFrame: Baseline, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks
Secondary outcomes:
measure: Other key measures of behavior and quality of life associated with autism
timeFrame: Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
city: Sacramento
country: United States
facility: University of California, Davis, M.I.N.D. Institute
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Orange City
country: United States
facility: Lake Mary Pediatrics
state: Florida
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Shreveport
country: United States
facility: Louisiana State University
state: Louisiana
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Manhattan
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma State University, Child Study Center
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research Center
state: Oregon
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Universtiy of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas, Houston
state: Texas
city: Clinton
country: United States
facility: Ericksen Research & Development
state: Utah
Study officials:
affiliation: Ohio State University, Nisonger Center
name: Eugene Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References: