A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents with Autism Spectrum Disorders | C4C

The aim of the study is to explore the efficacy, safety and tolerability of arbaclofen for the treatment of the social difficulties associated with autism spectrum disorder in children aged 5-17 years. The medication will be tested in a randomised, placebo-controlled trial lasting 16 weeks. We aim to include 130 young people with ASD. Those who are eligible to take part in the study will be allocated by chance (randomised) to receive either arbaclofen or placebo. The study will be double-blind, i.e., neither the researchers or the participants will know whether they have been allocated to the medication or the placebo arm.