Essai clinique
Récupéré
Publication
clinicaltrials.gov
Hadassah Medical Organization
(2014).
TSO in Pediatric Autistic Spectrum Disorders.
ClinicalTrials.gov.
Hadassah Medical Organization.
- Date de publication
-
2014
- Identifiant
-
NCT01734941
- Auteurs
-
Hadassah Medical Organization
- Source
- ClinicalTrials.gov
- Type de référence
- clinical_trial
- Éditeur
- Hadassah Medical Organization
- Source de métadonnées
- clinicaltrials.gov
Résumé
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)