search
Back to results

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

Primary Purpose

Autism

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trichuris suis ova
Placebo
Sponsored by
Coronado Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring T. suis ova, Trichuris suis ova, Autism Spectrum Disorder, ASD

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Autism Research & Resource Center
  • Arkansas Children's Hospital Research Institute
  • Baber Research Group
  • Montefiore Medical Center Dept. of Psychiatry, Child Annex
  • Red Oak Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Trichuris suis ova

Placebo

Arm Description

TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks

Placebo 8 doses every 2 weeks

Outcomes

Primary Outcome Measures

Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks

Secondary Outcome Measures

Full Information

First Posted
May 13, 2014
Last Updated
November 3, 2015
Sponsor
Coronado Biosciences, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02140112
Brief Title
Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo in Autism Spectrum Disorder
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
A preliminary analysis of data from this trial failed to demonstrate any signal of activity.
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coronado Biosciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
T. suis ova, Trichuris suis ova, Autism Spectrum Disorder, ASD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trichuris suis ova
Arm Type
Active Comparator
Arm Description
TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 8 doses every 2 weeks
Intervention Type
Biological
Intervention Name(s)
Trichuris suis ova
Other Intervention Name(s)
TSO
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Southwest Autism Research & Resource Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Baber Research Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Montefiore Medical Center Dept. of Psychiatry, Child Annex
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Red Oak Psychiatry
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs