Trial · NCT03715153
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
NCT03715153, Phase 3, Terminated, Institut de Recherches Internationales Servier; results first posted 2023-06-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder. Trials, record NCT03715153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03715153
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 Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
- NCT number
- NCT03715153
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 211 participants, actual
- Lead sponsor
- Institut de Recherches Internationales Servier
- Conditions
- Autism Spectrum Disorder (ASD)
- Interventions
- BUMETANIDE (S95008) for week 0 - 26, PLACEBO for week 0 - 26, Open-Label BUMETANIDE (S95008) for weeks 26 - 52
- First posted
- 2018-10-23
- Last updated
- 2023-06-05
- Other registries' IDs
- eudract:2017-004420-30
- Results first posted
- 2023-06-05
- Limitations and caveats
- The sponsor decided to stop the S95008 development and prematurely discontinue the extension period. This decision was not related to unexpected safety concerns.
Source ClinicalTrials.gov
Registered outcomes9
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 Week 26 | 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. |
| Secondary | Social Responsiveness Scale, Second Edition (SRS-2) Total Raw Score | Change from baseline to Week 26 | The SRS-2 total raw score serves as an index of severity of social deficits in the autism spectrum. The total raw score ranges from 65 to 260. A value of 65 represents no symptoms disorders, a value of 260 represents a severe autism spectrum disorder. In terms of change from baseline, the greater the mean value decreases, the better it is. |
| Secondary | Clinical Global Impression - Global Improvement (CGI-I) Score | At Week 26 | Scale which assesses the severity of the illness and the global improvement of the patient under study treatment. It ranges from 1 (normal) through to 7 (amongst the most severely ill patients). |
| Secondary | Vineland Adaptative Behaviour Scale II (VABS II) | Change from baseline to Week 26 | Scale designated to measure adaptative behaviour The scale for behaviour ranges from 1 to 67. The more the score decreases, the better it is. |
| Secondary | Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters | Week 26 | Number of patients with clinically significant ECG abnormalities The 12-lead electrocardiogram (ECG) is a medical test that is recorded using leads, or nodes, attached to the body. Electrocardiograms (ECGs), capture the electrical activity of the heart and transfer it to graphed paper where abnormalities are reported and interpretated by the cardiologist. |
| Secondary | Columbia-Suicide Severity Scale Children's Version (C-SSRS-C) | Week 26 | Number of patients with suicidal ideation or suicidal behavior. The scale is 0 to 5 with the highest suicidal behavior being a 5 and the absence of suicidal behavior or very minor behaviors are 0. However, statistical analysis was done by looking at the number of patients with suicidal behavior or suicidal ideation during their lifetime and during the last 6 months of treatment. |
| Secondary | Acceptability and Palatability Questionnaires - Only Descriptive Analyses | Week 26 | Acceptability and palatability criterion Based on your child's reactions (indirect rating), do you think that he/she found the administration method to be |
| Secondary | Paediatric Quality of Life Inventory (PedsQL) Questionnaire | Change from baseline to week 26 | It represents the assessment of parent/legal representative perception of patient health related quality of life The values of the questionnaire range from 0 to 100. Higher scores indicate better HRQOL (Health-Related Quality of Life) |
| Secondary | Number of Participants Experiencing at Least 1 Treatment Emergent Adverse Event (TEAE) | through week 52 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Childhood Autism Rating Scale, Second Edition (CARS2) Total Raw Score | Change from baseline to Week 26 | score on a scale | MEAN | |
| SECONDARY | Social Responsiveness Scale, Second Edition (SRS-2) Total Raw Score | Change from baseline to Week 26 | score on a scale | MEAN | |
| SECONDARY | Clinical Global Impression - Global Improvement (CGI-I) Score | At Week 26 | score on a scale | MEAN | |
| SECONDARY | Vineland Adaptative Behaviour Scale II (VABS II) | Change from baseline to Week 26 | score on a scale | MEAN | |
| SECONDARY | Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters | Week 26 | As this measure was collected through week 26, only data gathered during the double-blind period for arms Bumetanide and Placebo were collected. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Columbia-Suicide Severity Scale Children's Version (C-SSRS-C) | Week 26 | As this measure was collected through week 26, only data gathered during the double-blind period for arms Bumetanide and Placebo were collected. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Acceptability and Palatability Questionnaires - Only Descriptive Analyses | Week 26 | Missing values are cancelled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Paediatric Quality of Life Inventory (PedsQL) Questionnaire | Change from baseline to week 26 | As this measure was collected through week 26, only data gathered during the double-blind period for arms Bumetanide and Placebo were collected. | score on a scale | MEAN |
| SECONDARY | Number of Participants Experiencing at Least 1 Treatment Emergent Adverse Event (TEAE) | through week 52 | The overall number of participants analyzed reflects the total number of individual patients analyzed. However, since the statistical analysis of TEAE occurrence was separated by period (double-blind, and open-label) many patients were counted once for each period, and thus the sum of participants in each row is greater than the total number of individual participants analyzed. Not all patients who participated in the double-blind period continued into the open-label period. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Childhood Autism Rating Scale, Second Edition (CARS2) Total Raw Score | BUMETANIDE (S95008) | -3.66 | Standard Deviation 4.52 | score on a scale | |
| Childhood Autism Rating Scale, Second Edition (CARS2) Total Raw Score | PLACEBO | -3.88 | Standard Deviation 5.06 | score on a scale | |
| Social Responsiveness Scale, Second Edition (SRS-2) Total Raw Score | BUMETANIDE (S95008) | -16.3 | Standard Deviation 21.9 | score on a scale | |
| Social Responsiveness Scale, Second Edition (SRS-2) Total Raw Score | PLACEBO | -18.7 | Standard Deviation 24.8 | score on a scale | |
| Clinical Global Impression - Global Improvement (CGI-I) Score | BUMETANIDE (S95008) | 2.9 | Standard Deviation 0.8 | score on a scale | |
| Clinical Global Impression - Global Improvement (CGI-I) Score | PLACEBO | 3.1 | Standard Deviation 0.9 | score on a scale | |
| Vineland Adaptative Behaviour Scale II (VABS II) | BUMETANIDE (S95008) | 1.1 | Standard Deviation 6.1 | score on a scale | |
| Vineland Adaptative Behaviour Scale II (VABS II) | PLACEBO | 0.7 | Standard Deviation 5.3 | score on a scale | |
| Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters | BUMETANIDE (S95008) | 0 | Participants | ||
| Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters | PLACEBO | 0 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period (From W0 to W26) | STARTED | BUMETANIDE (S95008) Followed by Open-Label S95008 | 107 | |
| Double-blind Period (From W0 to W26) | STARTED | PLACEBO Followed by Open-Label S95008 | 104 | |
| Double-blind Period (From W0 to W26) | COMPLETED | BUMETANIDE (S95008) Followed by Open-Label S95008 | 90 | |
| Double-blind Period (From W0 to W26) | COMPLETED | PLACEBO Followed by Open-Label S95008 | 95 | |
| Double-blind Period (From W0 to W26) | NOT COMPLETED | BUMETANIDE (S95008) Followed by Open-Label S95008 | 17 | |
| Double-blind Period (From W0 to W26) | NOT COMPLETED | PLACEBO Followed by Open-Label S95008 | 9 | |
| Open-label Period (From W26 to W52) | STARTED | BUMETANIDE (S95008) Followed by Open-Label S95008 | 86 | |
| Open-label Period (From W26 to W52) | STARTED | PLACEBO Followed by Open-Label S95008 | 92 | |
| Open-label Period (From W26 to W52) | COMPLETED | BUMETANIDE (S95008) Followed by Open-Label S95008 | 46 | |
| Open-label Period (From W26 to W52) | COMPLETED | PLACEBO Followed by Open-Label S95008 | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events308
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood creatinine increased | Investigations | S95008 - Double-blind Period (Week 0-26) | 6 | 107 | 6 |
| other | Blood creatinine increased | Investigations | Placebo - Double-blind Period (Week 0-26) | 3 | 104 | 3 |
| other | Blood creatinine increased | Investigations | S95008/S95008 - Open-Label Extension Period (Week 26-52) | 11 | 84 | 11 |
| other | Blood creatinine increased | Investigations | Placebo/S95008 - Open-Label Extension Period (Week 26-52) | 5 | 92 | 5 |
| other | Blood uric acid increased | Investigations | S95008 - Double-blind Period (Week 0-26) | 5 | 107 | 6 |
| other | Blood uric acid increased | Investigations | Placebo - Double-blind Period (Week 0-26) | 0 | 104 | 0 |
| other | Blood uric acid increased | Investigations | S95008/S95008 - Open-Label Extension Period (Week 26-52) | 5 | 84 | 6 |
| other | Blood uric acid increased | Investigations | Placebo/S95008 - Open-Label Extension Period (Week 26-52) | 2 | 92 | 2 |
| other | Weight decreased | Investigations | S95008 - Double-blind Period (Week 0-26) | 13 | 107 | 13 |
| other | Weight decreased | Investigations | Placebo - Double-blind Period (Week 0-26) | 2 | 104 | 2 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | S95008 - Double-blind Period (Week 0-26) | 0 | 107 |
| Total, all-cause mortality | Placebo - Double-blind Period (Week 0-26) | 0 | 104 |
| Total, all-cause mortality | S95008/S95008 - Open-Label Extension Period (Week 26-52) | 0 | 84 |
| Total, all-cause mortality | Placebo/S95008 - Open-Label Extension Period (Week 26-52) | 0 | 92 |
| Total, other adverse events | S95008 - Double-blind Period (Week 0-26) | 103 | 107 |
| Total, other adverse events | Placebo - Double-blind Period (Week 0-26) | 96 | 104 |
| Total, other adverse events | S95008/S95008 - Open-Label Extension Period (Week 26-52) | 84 | 84 |
| Total, other adverse events | Placebo/S95008 - Open-Label Extension Period (Week 26-52) | 81 | 92 |
| Total, serious adverse events | S95008 - Double-blind Period (Week 0-26) | 7 | 107 |
| Total, serious adverse events | Placebo - Double-blind Period (Week 0-26) | 3 | 104 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BUMETANIDE (S95008) vs PLACEBO: Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters |
Source Trial comparisons
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/NCT03715153
GET https://conductscience.org/api/trials/v1/NCT03715153/results?page=2