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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)

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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)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Oct 2020

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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

    • 15 Sep 2020 Results assessing PK data for initial selection and confirmation of child and adolescent dosing to achieve equivalent balovaptan exposure to adults from this study, presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology.
    • 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.
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