NCT00912691

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_3

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

6.1 years

First QC Date

June 2, 2009

Last Update Submit

February 26, 2019

Conditions

Autism

Keywords

Autism

Outcome Measures

Primary Outcomes (1)

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

    Baseline, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks

Secondary Outcomes (1)

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

    Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks

Study Arms (1)

1

EXPERIMENTAL

CM-AT

Drug: CM-AT

Interventions

CM-ATDRUG

Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days

1

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Southwest Autism Research and Resource Center

Phoenix, Arizona, 85006, United States

Location

University of California, Davis, M.I.N.D. Institute

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Lake Mary Pediatrics

Orange City, Florida, 32763, United States

Location

Institute for Behavioral Medicine

Smyrna, Georgia, 30080, United States

Location

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Louisiana State University

Shreveport, Louisiana, 71103, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Mount Sinai School of Medicine

Manhattan, New York, 10029, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma State University, Child Study Center

Oklahoma City, Oklahoma, 73117, United States

Location

Cyn3rgy Research Center

Gresham, Oregon, 97030, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19124, United States

Location

Universtiy of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Texas, Houston

Houston, Texas, 77054, United States

Location

Ericksen Research & Development

Clinton, Utah, 84015, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Eugene Arnold, MD

    Ohio State University, Nisonger Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

January 1, 2010

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

US(19)