Status:
COMPLETED
Dose Finding Study of Pioglitazone in Children With Autism Spectrum Disorders (ASD) (PIO)
Lead Sponsor:
Evdokia Anagnostou
Collaborating Sponsors:
Holland Bloorview Kids Rehabilitation Hospital
Conditions:
Autism Spectrum Disorders
Eligibility:
All Genders
5-12 years
Phase:
PHASE2
Brief 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 measure...
Eligibility Criteria
Inclusion
- Male or female outpatients 5-12 years of age inclusive (see Note below).
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV) criteria. DSM-IV criteria for Autistic Disorder or Asperger's Disorder (autism spectrum disorder) will be confirmed by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-IV criteria, the Autism Diagnostic Observation Schedule (ADOS-G) and the Autism Diagnostic Interview-Revised (ADI-R).
- Have a Clinical Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Baseline.
- If already receiving stable non-pharmacologic educational, behavioural, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening and will not electively initiate new or modify ongoing interventions for the duration of the study.
- Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
Exclusion
- Patients born prior to 35 weeks gestational age.
- Families without sufficient command of the English Language.
- Patients with any primary psychiatric diagnosis other than autism at Screening.
- Patients with a current neurological disease, including, but not limited to, movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes.
- Pregnant female patients, female patients who are sexually active, female patients using the birth control pill for whatever reason.
- Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease. Patients with stable epilepsy (no seizures for 6 months) and on stable doses of antiepileptic medications (no changes in 3 months) will be allowed in the study.
- Patients taking psychoactive medication(s).
- Patients taking insulin.
- Patients unable to tolerate venipuncture procedures for blood sampling.
- Patients with parent(s)/caregiver(s) who smoke.
- Patients who have had previous bladder infection(s).
- Patients with a family history of bladder cancer.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01205282
Start Date
April 1 2013
End Date
September 1 2015
Last Update
March 20 2017
Active Locations (1)
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1
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G 1R8