Roche at ESSENCE 2018
Mar 20, 2019 | NeuroscienceMar 20, 2019 | Neuroscience
The phase 2 VANILLA trial (n=223) evaluated 3 doses of daily balovaptan, a selective vasopressin 1a receptor antagonist versus placebo in men with ASD and IQ≥70 for 12 weeks. The primary outcome was the change from baseline versus placebo at the 12-week on the Social Responsiveness Scale-2. A key secondary outcome was the change from baseline on the Vineland™-II Adaptive Behavior Scales, which assesses adaptive functioning and skills. Other secondary and exploratary measures included the Aberrant Behaviour Checklist, the Repetitive Behavior Scale-Revised, Clinical Global Impressions Improvement and the Pediatric Quality of Life Inventory™ Generic Core Scales v4.0. Safety outcomes included adverse events, and clinical and laboratory assessments.