A Multi-center, Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Proof of Concept Study to Investigate the Efficacy and Safety of RG7314 in Individuals With Autism Spectrum Disorders (ASD)
Phase of Trial: Phase II
Latest Information Update: 29 Jan 2018
At a glance
- Drugs Balovaptan (Primary)
- Indications Pervasive child development disorders
- Focus Adverse reactions; Proof of concept; Therapeutic Use
- Acronyms VANILLA
- Sponsors Roche
- 29 Jan 2018 According to a Roche media release, based on the results of this study, the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation balovaptan, for individuals with autism spectrum disorder (ASD).
- 01 Feb 2017 Status changed from active, no longer recruiting to completed.
- 01 Aug 2016 Status changed from recruiting to active, no longer recruiting.