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Clinical Trial Summary

This was a Phase Ib, multicenter, open-label study in children 2-4 years old with autism spectrum disorder (ASD) to investigate the pharmacokinetics, safety, and tolerability of an oral dose of balovaptan once a day (QD). The study was to consists of a 6-week treatment period to evaluate the pharmacokinetics of balovaptan in 2 to 4 year old children followed by an optional extension period of 48 weeks.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04049578
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Terminated
Phase Phase 1
Start date December 19, 2019
Completion date May 6, 2020

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