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A Phase II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)

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A Phase II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 14 Jul 2022

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At a glance

  • Drugs Balovaptan (Primary)
  • Indications Pervasive child development disorders
  • Focus Therapeutic Use
  • Acronyms aV1ation
  • Sponsors Roche

    • Most Recent Events

    • 06 Jul 2022 Results published in the JAMA Psychiatry
    • 08 Jul 2020 Status changed from active, no longer recruiting to discontinued (The 24-week analysis indicated no clinical or statistical benefit for the primary endpoint forthe overall study population. No new safety concerns identified).
    • 18 May 2020 Planned End Date changed from 6 Jul 2021 to 20 Jun 2020.

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