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

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