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

Phase 2

Terminated

• Conditions: Autism
• Interventions: Other: Placebo; Biological: Trichuris suis ova

• Registration Number: NCT02140112
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-16
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 8 doses every 2 weeks
Trichuris suis ova	Trichuris suis ova	TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks	36 weeks

Trial Locations

Locations (5)

Baber Research Group; 🇺🇸 Naperville, Illinois, United States

Montefiore Medical Center Dept. of Psychiatry, Child Annex; 🇺🇸 Bronx, New York, United States

Red Oak Psychiatry; 🇺🇸 Houston, Texas, United States

Arkansas Children's Hospital Research Institute; 🇺🇸 Little Rock, Arkansas, United States

Southwest Autism Research & Resource Center; 🇺🇸 Phoenix, Arizona, United States