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A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD

NCT01661855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-07-16

No results posted yet for this study

Summary

This study will examine the potential efficacy and safety of riluzole for core and associated symptom domains of autism and will explore biological markers of safety and treatment response.

Conditions

  • Autism Spectrum Disorders

Interventions

DRUG

Riluzole

50mg once daily (QD) for 12 weeks for participants 6-11 years old; 50mg twice daily (BID) for 12 weeks for participants 12-17 years old

DRUG

Placebo

Placebo comparator once daily (QD) for 12 weeks for participants 6-11 years old; Placebo comparator twice daily (BID) for 12 weeks for participants 12-17 years old

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • The Hospital for Sick Children

    collaborator OTHER

  • The University of Western Ontario

    collaborator UNKNOWN

  • 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

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • Canada

Study Locations

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Entities

Drugs
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 NCT01661855 on ClinicalTrials.gov