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

Study Overview
=================
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.

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

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Biological: Trichuris suis ova
* Other: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trichuris suis ova<br>TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks | Biological: Trichuris suis ova<br> <br> * Other names: TSO;|
| Placebo Comparator: Placebo<br>Placebo 8 doses every 2 weeks | Other: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T. suis ova, Trichuris suis ova, Autism Spectrum Disorder, ASD