NCT03887676

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

A Randomized Placebo-controlled Trial of ARBaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Holland Bloorview Kids Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed description

There are no pharmacologic treatments available for social function deficits in individuals with ASD. The data for pharmacologic treatment of repetitive behaviours in this disorder has also become difficult to interpret given that the last two large multisite trials of selective serotonin reuptake inhibitors (SSRIs) in autism are reported to be negative for the treatment of repetitive behaviours. Only the associated symptom of irritability has 2 drugs with Food and Drug Administration (FDA) indications, whereas no systematic data exists on the pharmacologic treatment of anxiety in ASD, and response to rates to stimulants for hyperactivity are lower than what is seen in Attention Deficit Hyperactivity Disorder (ADHD). In addition, there are no biological markers of treatment response identified in this population at this point. This study will examine the potential efficacy and safety of arbaclofen for social function, and will explore biological markers of safety and treatment response.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-18
• Primary completion: 2023-08-04
• Completion: 2023-08-04
• First posted: 2019-03-25
• Last updated: 2025-07-16

Locations

4 sites across 1 country: Canada