Published on The Nathan Kline Institute for Psychiatric Research (https://www.nki.rfmh.org)

Home > 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

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: 

Clinical Evaluation Center at 845-398-2184 or vrp@nki.rfmh.org [2].


Source URL: https://www.nki.rfmh.org/content/phase-iii-randomized-double-blind-placebo-controlled-efficacy-and-safety-study-balovaptan

Links
[1] https://www.nki.rfmh.org/content/phase-iii-randomized-double-blind-placebo-controlled-efficacy-and-safety-study-balovaptan
[2] mailto:vrp@nki.rfmh.org