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Efficacy and safety of bumetanide oral liquid formulation in children aged from 2 to less than 7 years old with Autism Spectrum Disorder. A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop

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Trial Profile

Efficacy and safety of bumetanide oral liquid formulation in children aged from 2 to less than 7 years old with Autism Spectrum Disorder. A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2023

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At a glance

  • Drugs Bumetanide (Primary)
  • Indications Autistic disorder; Pervasive child development disorders
  • Focus Therapeutic Use
  • Sponsors Servier
  • Most Recent Events

    • 23 Sep 2023 This trial has been Discontinued in Poland, Ireland, Slovakia, Italy , according to European Clinical Trials Database.
    • 22 Jul 2022 This trial has been completed in Spain and Portugal (end date: 26 Oct 2021), according to Last checked against European Clinical Trials Database record.
    • 22 Dec 2021 This trial has been completed in Czech Republic (Global end date: 26 Oct 2021).
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