Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Coronado Biosciences, Inc.
Age
5–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo in Autism Spectrum Disorder
