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

NCT02140112 | Terminated Phase 2

• 1 other identifier: CNDO 201-101
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

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.

Conditions

Autism

Keywords

T. suis ova; Trichuris suis ova; Autism Spectrum Disorder; ASD

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks

  36 weeks

Study Arms (2)

Trichuris suis ova

ACTIVE COMPARATOR

TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks

Biological: Trichuris suis ova

Placebo

PLACEBO COMPARATOR

Placebo 8 doses every 2 weeks

Other: Placebo

Interventions

Trichuris suis ova BIOLOGICAL

Also known as: TSO

Trichuris suis ova

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Coronado Biosciences, Inc.: lead

Study Sites (5)

Southwest Autism Research & Resource Center

Phoenix, Arizona, 85006, United States

Location

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

Montefiore Medical Center Dept. of Psychiatry, Child Annex

The Bronx, New York, 10467, United States

Location

Red Oak Psychiatry

Houston, Texas, 77090, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

US (5)