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Balovaptan Fails to Improve Social Communication in Autism Spectrum Disorder
The oral selective vasopressin 1a (V1a) receptor antagonist balovaptan did not demonstrate efficacy in improving socialization and communication in a randomized clinical trial of children and adolescents with autism spectrum disorder. Researchers published their study online ahead of print in JAMA Psychiatry.
“Results suggest that V1a receptor antagonism does not improve social and communication function in pediatric autism spectrum disorder,” wrote lead and corresponding author Eric Hollander, MD, of the Albert Einstein College of Medicine Department of Psychiatry and Behavioral Sciences, Bronx, New York, and coauthors.
The aV1ation study included 167 participants ages 5 to 17 with pediatric autism spectrum disorder and an IQ of 70 or greater: 86 were randomized to age-adjusted balovaptan equivalent to a 10-mg adult dose, and 81 to placebo. The study spanned 41 sites throughout the United States.
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At week 24, change from baseline on the Vineland-II two-domain composite score — the study’s primary endpoint, which focused on socialization and communication — did not differ between the balovaptan and placebo groups, researchers reported. Secondary endpoints, too, failed to show improvement with balovaptan compared with placebo.
The study did find that balovaptan was well tolerated in participants. Rates of reported adverse events were similar with balovaptan and placebo (76.7% and 75.3%, respectively), as were rates of serious adverse events (1.2% and 4.9%, respectively).
“Importantly, this work emphasizes ongoing challenges in the identification of treatments targeting core symptoms associated with autism spectrum disorder and highlights important study design considerations for future autism spectrum disorder trials and related disorders,” researchers wrote. “Results from this trial can guide future drug development efforts in autism spectrum disorder based on candidate treatment mechanisms of action.”
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