Autism Spectrum Disorder (ASD)Phase 3NCT03715153
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 testing BUMETANIDE (S95008) for week 0 - 26 and Open-Label BUMETANIDE (S95008) for weeks 26 - 52 in people with Autism Spectrum Disorder (ASD), run by Institut de Recherches Internationales Servier at 50 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- BUMETANIDE (S95008) for week 0 - 26 and Open-Label BUMETANIDE (S95008) for weeks 26 - 52
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 50 sitesin 12 countries
- Study dates
- 4 Oct 2018to 26 Oct 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female patients from 2 to less than 7
- Primary diagnosis of ASD as per Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria
- Criteria met for ASD on Autism Diagnostic Observation Schedule-Generic (ADOS-2) and Autism Diagnosis Interview Revised (ADI-R)
- CGI (Clinical Global Impression) - Severity rating Score ≥ 4
- Childhood Autism Rating Scale second edition (CARS2-ST or HF) total raw score ≥ 34
- Social responsiveness Scale second edition (SRS-2) total score ≥ 66 T-Score
- Absence of diagnosis of Fragile X or Rett Syndrome
- Absence of any clinically significant abnormality likely to interfere with the conduct of the study according to the judgment of the investigator.
Who cannot join
- Patients not able to follow the study assessments defined by the protocol, with the exception of self-rating questionnaires which will be assessed by parent/legal representative/caregiver for those patients unable to complete them
- Patients having a high suicidal risk according to the investigator judgement
- Chronic renal dysfunction
- Chronic cardiac dysfunction
- Patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural therapy
- Severe electrolyte imbalance that is likely to interfere with the study conduct or evaluation
Trial locations and contacts
50 sites in 12 countries.
50 sites in 12 countries
France9 sites
Centre Hospitalier Charles Perrens CRA Aquitaine
Bordeaux, New Aquitaine, 33076
Hôpital des Enfants-Pellegrin
Bordeaux, New Aquitaine, 33076
Centre d'Investigation Clinique de Lyon
Bron, Auvergne-Rhône-Alpes, 69677
Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211
Bron, Auvergne-Rhône-Alpes, 69678
GSC CHU-LENVAL Centre ressource autisme
Nice, Alpes-Maritimes, 6200
Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent
Paris, Île-de-France Region, 75019
CHU Rouen
Rouen, Normandy, 76000
Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme
Sotteville-lès-Rouen, Normandy, 76301
Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent
Strasbourg, Grand Est, 67091
Spain7 sites
Hospital General Universitario de Alicante
Alicante, 03007
Hospital Clinic de Barcelona
Barcelona, 08036
Policlinica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Niño Jesus
Madrid, 28009
Hospital Universitario Gregorio Marañon
Madrid, 28009
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
Hospita Mutua de Terrassa
Terrassa, Barcelona, 08221
Brazil6 sites
Trial Tech em Pesquisas com Medicamentos Ltda
Curitiba, 80240-280
Hospital Universitário Walter Cantídio-Universidade Federal do Ceará
Fortaleza, 60430-370
Clínica Neurológica e Neurocirúrgica de Joinville
Joinville, 89202-190
Hospital São Vicente de Paulo
Passo Fundo, 99010-080
Universidade Federal de São Paulo, Escola Paulista de Medicina
São Paulo, 04017-030
Faculdade de Medicina da Universidade de São Paulo - Departamento de psiquiatra
São Paulo, 054030-010
Italy6 sites
Neuro Riabilitazione/Psicopatologia dell'età evolutiva Istituto Scientifico Medea - Bosisio Parini
Bosisio Parini, Lombardy, 23842
Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza Ospedale Pediatrico-Microcitemico
Cagliari, Sardinia, 09131
U.O.C. Psichiatria dello Sviluppo IRCCS Fondazione Stella Maris
Calambrone, Tuscany, 56128
Programma Interdipartimentale "Autismo 0-90" A.O.U. Policlinico "Gaetano Martino"
Messina, Sicily, 98125
U.O. di Neuropsichiatria Infantile Fondazione Istituto Neurologico Nazionale Casimiro Mondino Istituto di Ricovero e Cura a Carattere Scientifico
Pavia, Lombardy, 27100
U.O. di Neuropsichiatria Infantile Azienda Ospedaliera Universitaria Senese
Siena, Tuscany, 53100
Hungary5 sites
Vadaskert Korhaz es Szakambulancia
Budapest, 1021
Servus Salvus Kft.
Budapest, 1026
Magyar Református Egyház Bethesda Gyermekkórháza
Budapest, 1143
Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly
Gyula, 5700
Szegedi Tudományegyetem Szent-Gyorgy Albert Klinikai Kozpont Gyermekgyógyászati Klinika Gyermek es Ifjusagpszichiátriai o
Szeged, 6725
Poland5 sites
"Niepubliczny Zakład Opieki Zdrowotnej Gdańskie Centrum Zdrowia Sp. z o.o.
Gdansk, 80-542
Centrum Badań Klinicznych PI-House sp. z o.o
Gdansk, 80-546
NAVICULA Centrum Diagnozy i Terapii Autyzmu w Łodzi
Lodz, 91-126
Fundacja SYNAPSIS ul.
Warsaw, 02-085
Samodzielny Publiczny Dziecięcy Szpital Kliniczny w Warszawie Oddział Kliniczny Psychiatrii Wieku Rozwojowego
Warsaw, 02-091
Czechia3 sites
University Hospital Brno, Department of Child Neurology
Brno, 613 00
University hospital of Ostrava, Department of Psychiatry
Poruba, Ostrava
Institute of Neuropsychiatric Care, Department of Child Psychiatry
Prague, 186 00
United Kingdom3 sites
Colchester Hospital
Colchester, CO4 5JL
ReCognition Health
London, W1G 9JF
The Winnicott Centre 195-197 Hathersage Road
Manchester, M13 0JE
Australia2 sites
Liverpool Hospital
Liverpool, 2170
The Royal Children's Hospital Melbourne
Parkville, 3052
Slovakia2 sites
National Institute of Children Diseases, Department of Child Psychiatry
Bratislava, 833 40
EPAMED, s.r.o.
Košice, 040 01
United States1 site
Richmond Behavioral Associates
Staten Island, New York, 10312
Portugal1 site
Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico
Coimbra, 300-062
About this study
Official title: 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.
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.
Read the detailed description
The present study (CL3-95008-002) was performed in children from 2 to less than 7 years old presenting with ASD. A 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg BID were assessed versus placebo. This double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg twice daily in which long term safety was evaluated.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- BUMETANIDE (S95008) for week 0 - 26, PLACEBO for week 0 - 26, Open-Label BUMETANIDE (S95008) for weeks 26 - 52
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUMETANIDE (S95008) for week 0 - 26Drug
Oral solution dosed at 0.5 mg/mL Taken twice daily.
PLACEBO for week 0 - 26Drug
Oral solution Taken twice daily.
Open-Label BUMETANIDE (S95008) for weeks 26 - 52Drug
Oral solution dosed at 0.5 mg/mL Taken twice daily.
| Study group | Role | What they receive |
|---|---|---|
| BUMETANIDE (S95008) followed by Open-Label S95008 | Experimental | Participants will receive S95008 for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008. Receives: Drug: BUMETANIDE (S95008) for week 0 - 26; Drug: Open-Label BUMETANIDE (S95008) for weeks 26 - 52 |
| PLACEBO followed by Open-Label S95008 | Placebo comparator | Participants will receive placebo for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008. Receives: Drug: PLACEBO for week 0 - 26; Drug: Open-Label BUMETANIDE (S95008) for weeks 26 - 52 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating Scale, Second Edition (CARS2) Total Raw Score
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.
Measured: Change from baseline to Week 26
Secondary outcomes (8)
Social Responsiveness Scale, Second Edition (SRS-2) Total Raw Score
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.
Measured: Change from baseline to Week 26
Clinical Global Impression - Global Improvement (CGI-I) Score
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).
Measured: At Week 26
Vineland Adaptative Behaviour Scale II (VABS II)
Scale designated to measure adaptative behaviour The scale for behaviour ranges from 1 to 67. The more the score decreases, the better it is.
Measured: Change from baseline to Week 26
Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters
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.
Measured: Week 26
Columbia-Suicide Severity Scale Children's Version (C-SSRS-C)
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.
Measured: Week 26
Acceptability and Palatability Questionnaires - Only Descriptive Analyses
Acceptability and palatability criterion Based on your child's reactions (indirect rating), do you think that he/she found the administration method to be
Measured: Week 26
Paediatric Quality of Life Inventory (PedsQL) Questionnaire
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)
Measured: Change from baseline to week 26
Number of Participants Experiencing at Least 1 Treatment Emergent Adverse Event (TEAE)
Measured: through week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start4 Oct 2018
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6-month, randomized, double-blind, placebo-controlled, parallel groups followed by an open label active 6-month treatment period with bumetanide.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715153
- Sponsor's protocol ID
- CL3-95008-002
- Other IDs
- 2017-004420-30, 2017
- Status last verified
- May 2023
- First submitted
- 12 Oct 2018
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Publications
Hawken N, Falissard B, Choquet C, Francois C, Tardu J, Schmid R. Exit interviews from two randomised placebo-controlled phase 3 studies with caregivers of young children with autism spectrum disorder. Front Child Adolesc Psychiatry. 2024 Jun 5;3:1236340. doi: 10.3389/frcha.2024.1236340. eCollection 2024.
PubMed 39816573Fuentes J, Parellada M, Georgoula C, Oliveira G, Marret S, Crutel V, Albarran C, Lambert E, Penelaud PF, Ravel D, Ben Ari Y. Bumetanide oral solution for the treatment of children and adolescents with autism spectrum disorder: Results from two randomized phase III studies. Autism Res. 2023 Oct;16(10):2021-2034. doi: 10.1002/aur.3005. Epub 2023 Oct 4.
PubMed 37794745
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03715153
- Acronym / sponsor ID
- CL3-95008-002
- Conditions
- Autism Spectrum Disorder (ASD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study (CL3-95008-002) was performed in children from 2 to less than 7 years old presenting with ASD. A 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg BID were assessed versus placebo. This double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg twice daily in which long term safety was evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 6-month, randomized, double-blind, placebo-controlled, parallel groups followed by an open label active 6-month treatment period with bumetanide.
| Arm | Type | Receives |
|---|---|---|
| BUMETANIDE (S95008) followed by Open-Label S95008 | Experimental | Drug: BUMETANIDE (S95008) for week 0 - 26, Drug: Open-Label BUMETANIDE (S95008) for weeks 26 - 52Participants will receive S95008 for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008. |
| PLACEBO followed by Open-Label S95008 | Placebo comparator | Drug: PLACEBO for week 0 - 26, Drug: Open-Label BUMETANIDE (S95008) for weeks 26 - 52Participants will receive placebo for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male and female patients from 2 to less than 7
- Primary diagnosis of ASD as per Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria
- Criteria met for ASD on Autism Diagnostic Observation Schedule-Generic (ADOS-2) and Autism Diagnosis Interview Revised (ADI-R)
- CGI (Clinical Global Impression) - Severity rating Score ≥ 4
- Childhood Autism Rating Scale second edition (CARS2-ST or HF) total raw score ≥ 34
Key exclusion criteria (6 listed)
- Patients not able to follow the study assessments defined by the protocol, with the exception of self-rating questionnaires which will be assessed by parent/legal representative/caregiver for those patients unable to complete them
- Patients having a high suicidal risk according to the investigator judgement
- Chronic renal dysfunction
- Chronic cardiac dysfunction
- Patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BUMETANIDE (S95008) for week 0 - 26Oral solution dosed at 0.5 mg/mL Taken twice daily. | Drug | BUMETANIDE (S95008) followed by Open-Label S95008 |
| PLACEBO for week 0 - 26Oral solution Taken twice daily. | Drug | PLACEBO followed by Open-Label S95008 |
| Open-Label BUMETANIDE (S95008) for weeks 26 - 52Oral solution dosed at 0.5 mg/mL Taken twice daily. | Drug | BUMETANIDE (S95008) followed by Open-Label S95008, PLACEBO followed by Open-Label S95008 |
Primary outcome
Childhood Autism Rating Scale, Second Edition (CARS2) Total Raw Score
Time frame: 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.
8 secondary outcomes
Social Responsiveness Scale, Second Edition (SRS-2) Total Raw Score
Time frame: Change from baseline to Week 26
Clinical Global Impression - Global Improvement (CGI-I) Score
Time frame: At Week 26
Vineland Adaptative Behaviour Scale II (VABS II)
Time frame: Change from baseline to Week 26
Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters
Time frame: Week 26
Columbia-Suicide Severity Scale Children's Version (C-SSRS-C)
Time frame: Week 26
Acceptability and Palatability Questionnaires - Only Descriptive Analyses
Time frame: Week 26
Paediatric Quality of Life Inventory (PedsQL) Questionnaire
Time frame: Change from baseline to week 26
Number of Participants Experiencing at Least 1 Treatment Emergent Adverse Event (TEAE)
Time frame: through week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39816573Hawken N, Falissard B, Choquet C, Francois C, Tardu J, Schmid R. Exit interviews from two randomised placebo-controlled phase 3 studies with caregivers of young children with autism spectrum disorder. Front Child Adolesc Psychiatry. 2024 Jun 5;3:1236340. doi: 10.3389/frcha.2024.1236340. eCollection 2024.
- Derived from this study: PubMed 37794745Fuentes J, Parellada M, Georgoula C, Oliveira G, Marret S, Crutel V, Albarran C, Lambert E, Penelaud PF, Ravel D, Ben Ari Y. Bumetanide oral solution for the treatment of children and adolescents with autism spectrum disorder: Results from two randomized phase III studies. Autism Res. 2023 Oct;16(10):2021-2034. doi: 10.1002/aur.3005. Epub 2023 Oct 4.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BUMETANIDE (S95008) for week 0 - 26 and Open-Label BUMETANIDE (S95008) for weeks 26 - 52 in people with Autism Spectrum Disorder (ASD), run by Institut de Recherches Internationales Servier at 50 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in France, Spain, Brazil, Italy, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale, Second Edition (CARS2) Total Raw Score (time frame: Change from baseline to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.