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.
There are no pharmacologic treatments available for social function deficits in individuals with Autism Spectrum Disorders (ASD). The data for pharmacologic treatment of repetitive behaviors 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 behaviors. Only the associated symptom of irritability has 2 drugs with 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 riluzole for core and associated symptom domains of autism and will explore biological markers of safety and treatment response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
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
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
Offord Centre for Child Studies
Hamilton, Ontario, Canada
Lawson Health Research Institute
London, Ontario, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada
Efficacy of riluzole vs. placebo on measures of social function
This will be measured by the Aberrant Behavior Checklist (ABC) - Lethargy / Social Withdrawal Subscale
Time frame: 12 weeks
Efficacy of riluzole vs. placebo on measures of repetitive behaviors
This will be measured by the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time frame: 12 weeks
Efficacy of riluzole vs. placebo on measures of repetitive behaviors
This will be measured by the Repetitive Behavior Scale (RBS-R)
Time frame: 12 weeks
Safety and tolerability of riluzole in children and adolescents with ASD
This will be measured by the Safety Monitoring Uniform Report Form (SMURF)
Time frame: 12 Weeks
Safety and tolerability of riluzole in children and adolescents with ASD
This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global)
Time frame: 12 Weeks
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