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

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ClinicalTrials.gov Identifier: NCT02140112
Recruitment Status : Terminated (A preliminary analysis of data from this trial failed to demonstrate any signal of activity.)
First Posted : May 16, 2014
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Coronado Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Autism Biological: Trichuris suis ova Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2014
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: TSO
Placebo Comparator: Placebo
Placebo 8 doses every 2 weeks
Other: Placebo



Primary Outcome Measures :
  1. Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks [ Time Frame: 36 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140112


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

Responsible Party: Coronado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02140112     History of Changes
Other Study ID Numbers: CNDO 201-101
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by Coronado Biosciences, Inc.:
T. suis ova
Trichuris suis ova
Autism Spectrum Disorder
ASD

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders