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An Open Label Study of CM-AT for the Treatment of Children With Autism
NCT02649959 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.
Conditions Studied
Interventions
- DRUG CM-AT
Study Locations (20)
California
- N.R.C. Research Institute — Orange
- M.I.N.D. Institute (Univ.of California, Davis) — Sacramento
- University of California (U.C.S.F.) — San Francisco
Florida
- Segal Institute For Clinical Research — North Miami
- Advent Health -Lake Mary Pediatrics — Orange City
- A.P.G. Research — Orlando
New Jersey
- Children'S Specialized Hospital — Egg Harbor
- Children's Specialized Hospital — Toms River
- Clinical Research Center of Nj — Voorhees Township
Arizona
- Southwest Autism Research & Resource Center (S.A.R.R.C.) — Phoenix
- University of Arizona, Pediatrics Multidisciplinary Research Unit — Tucson
Louisiana
- Lake Charles Clinical Trials — Lake Charles
- L.S.U. Health Sciences Center — Shreveport
Arkansas
- Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.) — Little Rock
Colorado
- IMMUNOe Research Centers — Centennial
Connecticut
- Yale Child Study Center — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2015-10 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02649959
The ClinicalTrials.gov registry entry for NCT02649959 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 405 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Curemark, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 1 intervention — of which CM-AT is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02649959 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02649959 about?
NCT02649959 is a clinical study titled "An Open Label Study of CM-AT for the Treatment of Children With Autism". This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.
What is the current status of trial NCT02649959?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2015-10. Estimated completion is 2028-01.
What conditions does trial NCT02649959 study?
This clinical trial studies the following conditions: Autism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02649959?
The interventions under investigation include: CM-AT (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02649959?
This trial is sponsored by Curemark, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02649959 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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