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GABA-B Agonist

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

Phase 2
Waitlist Available
Led By Evdokia Anagnostou, M.D
Research Sponsored by Evdokia Anagnostou
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks

Summary

This trial will test if arbaclofen can improve social skills in children and teenagers with Autism Spectrum Disorder (ASD). Currently, there are no medications specifically for social difficulties in ASD. Arbaclofen might help by balancing brain chemicals involved in social behavior. Previous trials have indicated the potential of arbaclofen for improving social function among autistic children and adolescents with fluent speech.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain
Secondary study objectives
Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale
Clinical Global Impressions - Impression Scale - Global (CGI-I-Global)
Clinical Global Impressions - Impression Scale - Improvement (CGI-I)
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ArbaclofenActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of TorontoOTHER
721 Previous Clinical Trials
1,115,169 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
589 Patients Enrolled for Autism Spectrum Disorder
Evdokia AnagnostouLead Sponsor
11 Previous Clinical Trials
554 Total Patients Enrolled
10 Trials studying Autism Spectrum Disorder
535 Patients Enrolled for Autism Spectrum Disorder
Holland Bloorview Kids Rehabilitation HospitalOTHER
67 Previous Clinical Trials
13,977 Total Patients Enrolled
23 Trials studying Autism Spectrum Disorder
8,771 Patients Enrolled for Autism Spectrum Disorder
McMaster UniversityOTHER
917 Previous Clinical Trials
2,616,163 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
523 Patients Enrolled for Autism Spectrum Disorder
University of Western Ontario, CanadaOTHER
166 Previous Clinical Trials
319,268 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
141 Patients Enrolled for Autism Spectrum Disorder
Queen's UniversityOTHER
374 Previous Clinical Trials
124,690 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
130 Patients Enrolled for Autism Spectrum Disorder
Unity Health TorontoOTHER
559 Previous Clinical Trials
455,356 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
441 Patients Enrolled for Autism Spectrum Disorder
Evdokia Anagnostou, M.DPrincipal InvestigatorHolland Bloorview Kids Rehabilitation Hospital
Robert Nicolson, M.DPrincipal InvestigatorUniversity of Western Ontario, Lawson Health Research Institute
Julia Frei, M.DPrincipal InvestigatorMcMaster University, Offord Centre for Child Studies
~13 spots leftby Dec 2025
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