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NCT03715153 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
A Phase 3 study, sponsored by Institut de Recherches Internationales Servier.
- Terminated
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
NCT03715153: Clinical Trial Phase 3 study, sponsored by Institut de Recherches Internationales Servier.
NCT03715153 is a Phase 3 study that was terminated before completion, run by Institut de Recherches Internationales Servier. The registered enrollment target is 211 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03715153, a Phase 3 study, was terminated before completion, sponsored by Institut de Recherches Internationales Servier.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.
Primary Outcome
The CARS2 total raw score range from 15 to 60. This scale is a behaviour rating scale intended to diagnose autism. A total score of 15 indicates that an individual behaviour is within normal limits, whereas a value of 60 indicates that the individual's behaviour is severly abnormal. In term of change from baseline, the greater the mean value decreases, the better it is.
Interventions
- DRUG BUMETANIDE (S95008) for week 0 - 26
- DRUG PLACEBO for week 0 - 26
- DRUG Open-Label BUMETANIDE (S95008) for weeks 26 - 52
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2021-10-26 |
| Phase | Phase 3 |
Why NCT03715153 stopped before completion
NCT03715153 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which BUMETANIDE (S95008) for week 0 - 26 is the first listed.
NCT03715153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03715153 about?
NCT03715153 is a clinical study titled "Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.". The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.
What is the current status of trial NCT03715153?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2018-10-04. Estimated completion is 2021-10-26.
What interventions are being tested in trial NCT03715153?
The interventions under investigation include: BUMETANIDE (S95008) for week 0 - 26 (DRUG), PLACEBO for week 0 - 26 (DRUG), Open-Label BUMETANIDE (S95008) for weeks 26 - 52 (DRUG).
Who is sponsoring clinical trial NCT03715153?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03715153's enrollment target sits among peer trials
211 1337th of 2000 higher than 663 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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