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

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Autism Spectrum Disorders
Interventions
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.

Trial Locations (1)

M4G 1R8

Holland Bloorview Kids Rehabilitation Hospital, Toronto

All Listed Sponsors
collaborator

Holland Bloorview Kids Rehabilitation Hospital

OTHER

lead

Evdokia Anagnostou

INDIV

NCT01205282 - Dose Finding Study of Pioglitazone in Children With Autism Spectrum Disorders (ASD) (PIO) | Biotech Hunter | Biotech Hunter