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A Phase Ib, Multicenter, Open-Label, 6-Week Study With a 48-Week Extension to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children Ages 2-4 Years With Autism Spectrum Disorder

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Trial Profile

A Phase Ib, Multicenter, Open-Label, 6-Week Study With a 48-Week Extension to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children Ages 2-4 Years With Autism Spectrum Disorder

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Balovaptan (Primary)
  • Indications Pervasive child development disorders
  • Focus Pharmacokinetics
  • Sponsors Roche

Most Recent Events

  • 13 May 2020 Status changed from recruiting to discontinued.
  • 26 Nov 2019 Planned initiation date changed from 30 Oct 2019 to 7 Jan 2020.
  • 16 Sep 2019 Status changed from not yet recruiting to recruiting.

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