Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo in Autism Spectrum Disorder

November 3, 2015 updated by: Coronado Biosciences, Inc.

A RANDOMIZED, DOUBLE-BLIND, PHASE 2A CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF TRICHURIS SUIS OVA FOR THE TREATMENT OF AUTISM SPECTRUM DISORDER

This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment and 16 weeks of placebo.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Southwest Autism Research & Resource Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Baber Research Group
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center Dept. of Psychiatry, Child Annex
    • Texas
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients, 5 to 17 years of age
  • Patients must fulfill DSM-V diagnostic criteria for autism spectrum disorder ascertained at screening, using a clinical review confirmed by the Autism Diagnosis Observation Schedule - Second edition (ADOS-2)
  • Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support patients' adherence to the study procedures must be obtained for patients who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the patient will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
  • Patients are able and willing to swallow study medication suspension.

Exclusion Criteria:

  • Known diagnosis of syndromal form of Autism (e.g. Rett Syndrome, Childhood Disintegrative Disorder, Fragile X Syndrome, etc.)
  • Patients who cannot discontinue anti-psychotic medication
  • Patients with current active seizure disorder or who have had a seizure within the last 6 months prior to screening
  • Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
  • Patients who have received helminthic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Trichuris suis ova
TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks
Biological: Trichuris suis ova
Other Names:
  • TSO
PLACEBO_COMPARATOR: Placebo
Placebo 8 doses every 2 weeks
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coronado Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (ESTIMATE)

May 16, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNDO 201-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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