A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults with Autism Spectrum Disorder with a 2-Year Open Label Extension [1]
This study will evaluate the efficacy, safety, and pharmacokinetics of 10mg of oral administration balovaptan QD compared with matching placebo in adults (18 years and older) with ASD.
Study Length:
Approximately 2.5 years
Disorder/Condition:
Autism Spectrum Disorder
Inclusion Criteria:
Males and Females, ages 18+ with high-functioning ASD (IQ > 70)
Study Title (brief):
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults with Autism Spectrum Disorder with a 2-Year Open Label Extension
Study Description (brief):
This study will evaluate the efficacy, safety, and pharmacokinetics of 10mg of oral administration balovaptan QD compared with matching placebo in adults (18 years and older) with ASD.
Study Contact:
Alexis Lieval, LCSW 845-398-2184, alexis.lieval@nki.rfmh.org [2]