Clinical trial
Fetched
Post
clinicaltrials.gov
Hadassah Medical Organization
(2014).
TSO in Pediatric Autistic Spectrum Disorders.
ClinicalTrials.gov.
Hadassah Medical Organization.
- Publication date
-
2014
- Identifier
-
NCT01734941
- Authors
-
Hadassah Medical Organization
- Source
- ClinicalTrials.gov
- Reference type
- clinical_trial
- Publisher
- Hadassah Medical Organization
- Metadata source
- clinicaltrials.gov
Abstract
The primary objective of this study is to evaluate and compare the safety and efficacy of Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism. Evaluation of the safety and tolerability of treatment with TSO in the target population across the dose range being tested is considered a primary objective, while the primary efficacy objective will be assessed via the change from baseline in the Aberrant Behavior Checklist (ABC) subscale scores. Dose response will be considered a primary objective as well. Secondary assessments of efficacy will be assessed via: • The change from baseline in the Clinical Global Impression scale (CGI-I)