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)

Trial Profile

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)

Completed
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
  • Most Recent Events

    • 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.
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