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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:
Information provided by (Responsible Party):
Coronado Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT02140112
First received: May 13, 2014
Last updated: November 3, 2015
Last verified: November 2015
  Purpose
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 Intervention Phase
Autism Biological: Trichuris suis ova Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Coronado Biosciences, Inc.:

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

Enrollment: 23
Study Start Date: May 2014
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Responsible Party: Coronado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02140112     History of Changes
Other Study ID Numbers: CNDO 201-101
Study First Received: May 13, 2014
Last Updated: November 3, 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

ClinicalTrials.gov processed this record on June 22, 2017