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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Autism

In brief

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.

Key facts

Study ID

NCT02140112

Run by

Coronado Biosciences, Inc.

People needed

23

Starts

2014-05-01

Expected to finish

2015-04-01

Last updated by the study team

2015-11-04

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Southwest Autism Research & Resource Center — Phoenix, Arizona, United States
• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
• Baber Research Group — Naperville, Illinois, United States
• Montefiore Medical Center Dept. of Psychiatry, Child Annex — The Bronx, New York, United States
• Red Oak Psychiatry — Houston, Texas, United States

Full record on ClinicalTrials.gov

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