deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT03715153

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.

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.

Sponsor: ADIR, a Servier Group company

Conditions Autism Spectrum Disorder (ASD)
Interventions BUMETANIDE (S95008) for week 0 - 26 Open-Label BUMETANIDE (S95008) for weeks 26 - 52 PLACEBO for week 0 - 26
Updated 18 times since 2018 Last updated: May 9, 2023 Started: Oct 4, 2018 Primary completion: Oct 26, 2021 Completion: Oct 26, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The 6-month efficacy analysis did not show any significant difference between bumetanide versus placebo in the treatment of ASD in the overall studied population. No unexpected safety concerns were identified.

Other terminated trials from ADIR, a Servier Group company

See all terminations from ADIR, a Servier Group company

Other Autism Spectrum Disorder (ASD) trials with similar outcome

Browse all Autism Spectrum Disorder (ASD) trials

A PHASE3 clinical study on Autism Spectrum Disorder (ASD), this trial is terminated or withdrawn. The trial is conducted by ADIR, a Servier Group company and has accumulated 18 data snapshots since 2018. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Jan 2020 · 5 months · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Feb 2022 · 12 months · monthly snapshot~Feb 2022 – ~Jul 2023 · 17 months · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Jul 2023 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Feb 2022 — Jul 2023 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

▶ Show 13 earlier versions

  1. Feb 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  2. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE3

  3. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  4. Oct 2020 — Dec 2020 [monthly]

    Recruiting PHASE3

  5. Aug 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  6. Apr 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  7. Jan 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  8. Aug 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  9. May 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  10. Mar 2019 — May 2019 [monthly]

    Recruiting PHASE3

  11. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  12. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  13. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

    First recorded

Oct 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • ADIR, a Servier Group company
  • Institut de Recherches Internationales Servier
Data source: Servier

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Alicante, Spain , Barcelona, Spain , Bordeaux, France , Bosisio Parini, Italy , Bratislava, Slovakia , Brno, Czechia , Bron, France , Budapest, Hungary , Cagliari, Italy , Calambrone, Italy and 32 more locations