A pilot dose finding study of pioglitazone in autistic children.

ABSTRACT:

Background

Pioglitazone is a promising compound for treatment of core autism spectrum disorder (ASD) symptoms as it targets multiple relevant pathways, including immune system alterations.

Objective

This pilot study aimed to elucidate the maximum tolerated dose, safety, preliminary evidence of efficacy, and appropriate outcome measures in autistic children ages 5-12 years old.

Methods

We conducted a 16-week prospective cohort, single blind, single arm, 2-week placebo run-in, dose-finding study of pioglitazone. Twenty-five participants completed treatment. A modified dose finding method was used to determine safety and dose response among three dose levels: 0.25 mg/kg, 0.5 mg/kg, and 0.75 mg/kg once daily.

Results

Maximum tolerated dose: there were no ser

SUBMITTER: Capano L 

PROVIDER: S-EPMC6258310 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature