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Tideglusib vs. Placebo in the Treatment of Adolescents With Autism Spectrum Disorders

NCT02586935 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-07-16

No results posted yet for this study

Summary

This study will examine the safety and efficacy of tideglusib vs. placebo for the treatment of core symptom domains in adolescents with Autism Spectrum Disorders

Conditions

  • Autism Spectrum Disorders

Interventions

DRUG

Tideglusib

Administered orally after dispersion in approximately 100 ml of water at dose levels of 400 to 1000 mg

OTHER

Placebo

Administered orally after dispersion in approximately 100 ml of water

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Western University, Canada

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Holland Bloorview Kids Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Evdokia Anagnostou, M.D. · Holland Bloorview Kids Rehabilitation Hospital

  • Terry Bennett, M.D. · MacMaster University, Offord Centre for Child Studies

  • Robert Nicolson, M.D. · University of Western Ontario, Lawson Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-10
Primary Completion
2018-02-25
Completion
2018-02-25

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02586935 on ClinicalTrials.gov