Trial · NCT03715166
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder
NCT03715166, Phase 3, Terminated, Institut de Recherches Internationales Servier
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder. Trials, record NCT03715166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03715166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder
- NCT number
- NCT03715166
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 211 participants, actual
- Lead sponsor
- Institut de Recherches Internationales Servier
- Conditions
- Autism Spectrum Disorder (ASD)
- Interventions
- Bumetanide Oral Solution, Placebo
- First posted
- 2018-10-23
- Last updated
- 2024-07-25
- Other registries' IDs
- eudract:2017-004419-38
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Childhood Autism Rating Scale, Second Edition (CARS2) total raw score | Change from baseline to 6 month | Efficacy criterion The CARS2 is a 15 item rated instrument. The rating values given for the 15 areas are summed to produce a Total score. |
| Secondary | Social Responsiveness Scale, Second Edition (SRS-2) total raw score | Change from baseline to 6 month | Efficacy criterion 65 items scale measuring symptoms associated with autism |
| Secondary | Clinical Global Impression - Global Improvement (CGI-I) score | At 6 months | Efficacy criterion Scale which assesses the severity of the illness and the global improvement of the patient under study treatment |
| Secondary | Vineland Adaptative Behaviour Sales, Second Edition (VABS II) subscores | Change from baseline to 6 month | Efficacy criterion Scale designated to measure adaptative behaviour |
| Secondary | Adverse events and Paediatric Adverse Event Rating Scale (PAERS) | On average of 52 weeks | Safety criterion Inventory report used to identify signs/symptoms experienced by the patient since the study treatment initiation. |
| Secondary | Abnormalities in 12-leads electrocardiogram (ECG) parameters | selection visit/Week004/Week008/Week012/Week 026/Week030/Week034/Week038/Week052 | Safety criterion |
| Secondary | Renal ultrasound | selection visit/Week026/Week052 | Safety criterion Assessment of the renal function |
| Secondary | the Columbia Suicide Severity Rating Scale Children's version (C-SSRS-C) | Week000/Week012/Week026/Week038/Week052 | Scale which assesses suicidal ideation and suicidal behaviour |
| Secondary | Tanner stage | Week000/Week026/Week052 | Safety criterion Assessment of Pubertal development |
| Secondary | Acceptability and palatability questionnaire | Week026 | Acceptability and palatability criterion Assessment of the ease of use to use the dosing device |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03715166
GET https://conductscience.org/api/trials/v1/NCT03715166/registered