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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trichuris suis ova

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

Group Type ACTIVE_COMPARATOR

Trichuris suis ova

Intervention Type BIOLOGICAL

Placebo

Placebo 8 doses every 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Trichuris suis ova

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Other Intervention Names

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TSO

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No