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

This study has been terminated.
(A preliminary analysis of data from this trial failed to demonstrate any signal of activity.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02140112
First Posted: May 16, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Coronado Biosciences, Inc.
May 13, 2014
May 16, 2014
October 12, 2017
May 2014
April 2015   (Final data collection date for primary outcome measure)
Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks [ Time Frame: 36 weeks ]
Same as current
Complete list of historical versions of study NCT02140112 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo in Autism Spectrum Disorder
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism
  • Biological: Trichuris suis ova
    Other Name: TSO
  • Other: Placebo
  • Active Comparator: Trichuris suis ova
    TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks
    Intervention: Biological: Trichuris suis ova
  • Placebo Comparator: Placebo
    Placebo 8 doses every 2 weeks
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02140112
CNDO 201-101
No
Not Provided
Not Provided
Coronado Biosciences, Inc.
Coronado Biosciences, Inc.
Not Provided
Not Provided
Coronado Biosciences, Inc.
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP