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

> **NCT03715153** · PHASE3 · TERMINATED · sponsor: **Institut de Recherches Internationales Servier** · enrollment: 211 (actual)

## Conditions studied

- Autism Spectrum Disorder (ASD)

## Interventions

- **DRUG:** BUMETANIDE (S95008) for week 0 - 26
- **DRUG:** PLACEBO for week 0 - 26
- **DRUG:** Open-Label BUMETANIDE (S95008) for weeks 26 - 52

## Key facts

- **NCT ID:** NCT03715153
- **Lead sponsor:** Institut de Recherches Internationales Servier
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2018-10-04
- **Primary completion:** 2021-10-26
- **Final completion:** 2021-10-26
- **Target enrollment:** 211 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2023-06-05

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03715153

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03715153, "Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT03715153. Licensed CC0.

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