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

Coronado Biosciences

Status and phase

Terminated

Phase 2

Conditions

Autism

Treatments

Other: Placebo

Biological: Trichuris suis ova

Study type

Interventional

Funder types

Industry

Identifiers

NCT02140112

CNDO 201-101

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

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