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NCT02649959 · ClinicalTrials.gov registry record · Phase 3

An Open Label Study of CM-AT for the Treatment of Children With Autism

A Phase 3 study of Autism, sponsored by Curemark.

Active
Registry status
Phase 3
Development phase
405
Enrollment target
20
Study locations

NCT02649959 is a Phase 3 study of Autism that is active but no longer recruiting, run by Curemark. The registered enrollment target is 405 participants, above the 180-participant average among 104 other Autism trials with a reported enrollment target (125% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT02649959, a Phase 3 study of Autism, is active but no longer recruiting, sponsored by Curemark.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
405 participants
Enrollment target
20
Study locations

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

FieldValue
Enrollment Target 405 participants
Start Date 2015-10
Est. Completion 2028-01
Phase Phase 3

Sponsor

Curemark

4 total trials

What the Registry Record Tells You About NCT02649959

The ClinicalTrials.gov registry entry for NCT02649959 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 405 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 180-participant average among 104 other Autism trials with a reported enrollment target (125% higher). The listed sponsor is Curemark, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT02649959 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, New Jersey.

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.

What interventions are being tested in trial NCT02649959?

The interventions under investigation include: CM-AT (DRUG).

Who is sponsoring clinical trial NCT02649959?

This trial is sponsored by Curemark, which has 4 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.