This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Administered orally as disintegrating tabs, round, white and beveled edges, at the following strengths: 5mg, 10mg, 15mg and 20mg
Administered orally as disintegrating tabs, round, white and beveled edges
McMaster University, Offord Centre for Child Studies
Hamilton, Ontario, Canada
Queen's Universtiy
Kingston, Ontario, Canada
University of Western Ontario, Lawson Health Research Institute
London, Ontario, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain
To examine the effect of arbaclofen vs. placebo social function
Time frame: 16 weeks
Clinical Global Impressions - Impression Scale - Improvement (CGI-I)
To examine the effect of arbaclofen vs. placebo on measures of global function
Time frame: 16 weeks
Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale
To examine the effect of arbaclofen vs. placebo on social withdrawal
Time frame: 16 weeks
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Communication Domain
To examine the effect of arbaclofen vs. placebo on communication
Time frame: 16 weeks
Safety Monitoring Uniform Report Form (SMURF)
To examine the safety and tolerability of arbaclofen in children and adolescents with ASD
Time frame: 16 weeks
Clinical Global Impressions - Impression Scale - Global (CGI-I-Global)
To examine the safety and tolerability of arbaclofen in children and adolescents with ASD
Time frame: 16 weeks
Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
To examine the safety and tolerability of arbaclofen in children and adolescents with ASD
Time frame: 16 weeks
Suicidality assessment using the Columbia-Suicide Severity Rating Scale (C-SSRS)
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To examine the safety and tolerability of arbaclofen in children and adolescents with ASD
Time frame: 16 weeks