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

Autism Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02140112
• Other study ID #: CNDO 201-101
• Status: Terminated
• Phase: Phase 2
• First received: May 13, 2014
• Last updated: November 3, 2015
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: Coronado Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Biological:
• Trichuris suis ova

Other:
• Placebo

Locations

Country	Name	City	State
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	Baber Research Group	Naperville	Illinois
United States	Southwest Autism Research & Resource Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Coronado Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks		36 weeks