A phase 2 randomized controlled trial (RCT) of balovaptan (BAL) in pediatric participants with autism spectrum disorder (ASD)
This presentation describes the primary, secondary and exploratory results from the aV1ation study (NCT02901431); a phase 2, double-blind, 24-week randomized controlled trial assessing the efficacy and safety of balovaptan versus placebo in pediatric and adolescent participants, 5–17 years of age, with autism spectrum disorder. The primary endpoint was change from baseline in the Vineland™-II two domain composite score (socialization and communication domains) at Week 24.