AutismPhase 3CM-ATNCT00912691
A Trial of CM-AT in Children With Autism- Open Label Extension Study
A Phase 3 study testing CM-AT in people with Autism, run by Curemark at 19 sites in United States.
Trial summary
The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- CM-AT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 19 sitesUnited States
- Study dates
- Jan 2010to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
Ericksen Research & Development
Clinton, Utah, 84015
Ohio State University
Columbus, Ohio, 43210
Cyn3rgy Research Center
Gresham, Oregon, 97030
Hershey Medical Center
Hershey, Pennsylvania, 17033
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
University of Texas, Houston
Houston, Texas, 77054
Mount Sinai School of Medicine
Manhattan, New York, 10029
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Oklahoma State University, Child Study Center
Oklahoma City, Oklahoma, 73117
Lake Mary Pediatrics
Orange City, Florida, 32763
Drexel University
Philadelphia, Pennsylvania, 19124
Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006
Universtiy of Pittsburgh
Pittsburgh, Pennsylvania, 15260
University of California, Davis, M.I.N.D. Institute
Sacramento, California, 95817
University of California, San Francisco
San Francisco, California, 94143
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701
Louisiana State University
Shreveport, Louisiana, 71103
Institute for Behavioral Medicine
Smyrna, Georgia, 30080
About this study
Official title: A Phase III Open Label Extension Study of CM-AT in Children With Autism
The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.
Read the 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.
- Conditions
- Autism
- Being tested
- CM-AT
- Keywords
- Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-ATDrug
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CM-AT Receives: Drug: CM-AT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of changes in behavior scales associated with the core symptoms of autism
Measured: 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
Measured: Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJan 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curemark
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Arnold, MD, Principal investigator, Ohio State University, Nisonger Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912691
- Sponsor's protocol ID
- 00102/Autism
- Acronym
- CM-AT
- Status last verified
- Feb 2019
- First submitted
- 2 Jun 2009
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Open Label Extension Study of CM-AT in Children With Autism
- ClinicalTrials.gov ID
- NCT00912691
- Acronym / sponsor ID
- CM-AT / 00102/Autism
- Conditions
- Autism
- Keywords
- Autism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- CuremarkIndustry (pharma, biotech, devices)
- Study start
- Jan 2010 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CM-ATCM-AT |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM-ATSingle unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days | Drug | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Arnold, MD principal investigator
Ohio State University, Nisonger Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CM-AT in people with Autism, run by Curemark at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.