NCT01205282

Dose Finding Study of Pioglitazone in Children With Autism Spectrum Disorders (ASD) (PIO)

A Pilot Dose Finding Study of Pioglitazone in Children With ASD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Evdokia Anagnostou · Individual
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose a pilot, single blind, placebo run-in, dose finding study of pioglitazone in children with autism with the ultimate goal of identifying appropriate dosing and outcome measures for a larger follow-up randomized placebo controlled clinical trial. The specific aims of this study are: 1) To examine the safety of pioglitazone in children with autism spectrum disorders (ASD) ages 5-12 years; 2) To identify appropriate outcome measures to be used in a follow-up multisite randomized control trial of pioglitazone in children with ASD; 3) To determine the maximum tolerated dose to be used in the follow-up multisite randomized controlled trial; 4) To examine the effect of pioglitazone on markers of inflammation (cytokine levels) and oxidative stress (superoxide dismutase, malonyl aldehydes); 5) To explore the relationship between different doses and response to treatment.

Conditions

• Autism Spectrum Disorders

Interventions

Type	Name	Description
DRUG	Pioglitazone	A modified dose finding method will be used to determine safety and dose response among three dose levels (0.25mg/kg QD, 0.5mg/kg QD, and 0.75mg/kg QD). The dose has been based on the per weight maximum adult dose. Specifically, the FDA has approved 45mg as the maximum adult dose. For a 60kg adult, this is 0.75mg/kg. There will be 14 weeks of active treatment.
DRUG	Placebo	There will be a 2 week period of placebo run-in.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2010-09-20
• Last updated: 2017-03-20

Locations

1 site across 1 country: Canada