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Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA)

NCT03887676 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-16

No results posted yet for this study

Summary

This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).

Conditions

Interventions

DRUG

Arbaclofen

Administered orally as disintegrating tabs, round, white and beveled edges, at the following strengths: 5mg, 10mg, 15mg and 20mg

OTHER

Placebo

Administered orally as disintegrating tabs, round, white and beveled edges

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Western University, Canada

    collaborator OTHER

  • Queen's University

    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

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

  • Julia Frei, M.D · McMaster University, Offord Centre for Child Studies

  • Muhammad Ayub, M.D · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2023-08-04
Completion
2023-08-04

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
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 NCT03887676 on ClinicalTrials.gov