Back to resultsEfficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
Primary Purpose
Autism Spectrum Disorder (ASD)
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BUMETANIDE (S95008) for week 0 - 26
PLACEBO for week 0 - 26
Open-Label BUMETANIDE (S95008) for weeks 26 - 52
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder (ASD)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Richmond Behavioral Associates
- Liverpool Hospital
- The Royal Children's Hospital Melbourne
- Trial Tech em Pesquisas com Medicamentos Ltda
- Hospital Universitário Walter Cantídio-Universidade Federal do Ceará
- Clínica Neurológica e Neurocirúrgica de Joinville
- Hospital São Vicente de Paulo
- Universidade Federal de São Paulo, Escola Paulista de Medicina
- Faculdade de Medicina da Universidade de São Paulo - Departamento de psiquiatra
- University hospital of Ostrava, Department of Psychiatry
- University Hospital Brno, Department of Child Neurology
- Institute of Neuropsychiatric Care, Department of Child Psychiatry
- GSC CHU-LENVAL Centre ressource autisme
- Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent
- Centre d'Investigation Clinique de Lyon
- Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211
- Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent
- CHU Rouen
- Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme
- Hôpital des Enfants-Pellegrin
- Centre Hospitalier Charles Perrens CRA Aquitaine
- Vadaskert Korhaz es Szakambulancia
- Servus Salvus Kft.
- Magyar Református Egyház Bethesda Gyermekkórháza
- Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly
- Szegedi Tudományegyetem Szent-Gyorgy Albert Klinikai Kozpont Gyermekgyógyászati Klinika Gyermek es Ifjusagpszichiátriai o
- Neuro Riabilitazione/Psicopatologia dell'età evolutiva Istituto Scientifico Medea - Bosisio Parini
- U.O. di Neuropsichiatria Infantile Fondazione Istituto Neurologico Nazionale Casimiro Mondino Istituto di Ricovero e Cura a Carattere Scientifico
- Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza Ospedale Pediatrico-Microcitemico
- Programma Interdipartimentale "Autismo 0-90" A.O.U. Policlinico "Gaetano Martino"
- U.O.C. Psichiatria dello Sviluppo IRCCS Fondazione Stella Maris
- U.O. di Neuropsichiatria Infantile Azienda Ospedaliera Universitaria Senese
- "Niepubliczny Zakład Opieki Zdrowotnej Gdańskie Centrum Zdrowia Sp. z o.o.
- Centrum Badań Klinicznych PI-House sp. z o.o
- NAVICULA Centrum Diagnozy i Terapii Autyzmu w Łodzi
- Fundacja SYNAPSIS ul.
- Samodzielny Publiczny Dziecięcy Szpital Kliniczny w Warszawie Oddział Kliniczny Psychiatrii Wieku Rozwojowego
- Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico
- National Institute of Children Diseases, Department of Child Psychiatry
- EPAMED, s.r.o.
- Hospita Mutua de Terrassa
- Policlinica Guipuzcoa
- Hospital Puerta de Hierro
- Hospital General Universitario de Alicante
- Hospital Clinic de Barcelona
- Hospital Niño Jesus
- Hospital Universitario Gregorio Marañon
- Colchester Hospital
- ReCognition Health
- The Winnicott Centre 195-197 Hathersage Road
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BUMETANIDE (S95008) followed by Open-Label S95008
PLACEBO followed by Open-Label S95008
Arm Description
Participants will receive S95008 for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008.
Participants will receive placebo for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
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.
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
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)
Number of Participants Experiencing at Least 1 Treatment Emergent Adverse Event (TEAE)
Full Information
NCT ID
NCT03715153
First Posted
October 12, 2018
Last Updated
May 9, 2023
Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company
1. Study Identification
Unique Protocol Identification Number
NCT03715153
Brief Title
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
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.
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
October 26, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder (ASD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
6-month, randomized, double-blind, placebo-controlled, parallel groups followed by an open label active 6-month treatment period with bumetanide.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BUMETANIDE (S95008) followed by Open-Label S95008
Arm Type
Experimental
Arm Description
Participants will receive S95008 for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008.
Arm Title
PLACEBO followed by Open-Label S95008
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008.
Intervention Type
Drug
Intervention Name(s)
BUMETANIDE (S95008) for week 0 - 26
Intervention Description
Oral solution dosed at 0.5 mg/mL Taken twice daily.
Intervention Type
Drug
Intervention Name(s)
PLACEBO for week 0 - 26
Intervention Description
Oral solution Taken twice daily.
Intervention Type
Drug
Intervention Name(s)
Open-Label BUMETANIDE (S95008) for weeks 26 - 52
Intervention Description
Oral solution dosed at 0.5 mg/mL Taken twice daily.
Primary Outcome Measure Information:
Title
Childhood Autism Rating Scale, Second Edition (CARS2) Total Raw Score
Description
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.
Time Frame
Change from baseline to Week 26
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale, Second Edition (SRS-2) Total Raw Score
Description
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.
Time Frame
Change from baseline to Week 26
Title
Clinical Global Impression - Global Improvement (CGI-I) Score
Description
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).
Time Frame
At Week 26
Title
Vineland Adaptative Behaviour Scale II (VABS II)
Description
Scale designated to measure adaptative behaviour The scale for behaviour ranges from 1 to 67. The more the score decreases, the better it is.
Time Frame
Change from baseline to Week 26
Title
Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters
Description
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.
Time Frame
Week 26
Title
Columbia-Suicide Severity Scale Children's Version (C-SSRS-C)
Description
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.
Time Frame
Week 26
Title
Acceptability and Palatability Questionnaires - Only Descriptive Analyses
Description
Acceptability and palatability criterion Based on your child's reactions (indirect rating), do you think that he/she found the administration method to be
Time Frame
Week 26
Title
Paediatric Quality of Life Inventory (PedsQL) Questionnaire
Description
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)
Time Frame
Change from baseline to week 26
Title
Number of Participants Experiencing at Least 1 Treatment Emergent Adverse Event (TEAE)
Time Frame
through week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
The Royal Children's Hospital Melbourne
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
Trial Tech em Pesquisas com Medicamentos Ltda
City
Curitiba
ZIP/Postal Code
80240-280
Country
Brazil
Facility Name
Hospital Universitário Walter Cantídio-Universidade Federal do Ceará
City
Fortaleza
ZIP/Postal Code
60430-370
Country
Brazil
Facility Name
Clínica Neurológica e Neurocirúrgica de Joinville
City
Joinville
ZIP/Postal Code
89202-190
Country
Brazil
Facility Name
Hospital São Vicente de Paulo
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Universidade Federal de São Paulo, Escola Paulista de Medicina
City
São Paulo
ZIP/Postal Code
04017-030
Country
Brazil
Facility Name
Faculdade de Medicina da Universidade de São Paulo - Departamento de psiquiatra
City
São Paulo
ZIP/Postal Code
054030-010
Country
Brazil
Facility Name
University hospital of Ostrava, Department of Psychiatry
City
Poruba
State/Province
Ostrava
Country
Czechia
Facility Name
University Hospital Brno, Department of Child Neurology
City
Brno
ZIP/Postal Code
613 00
Country
Czechia
Facility Name
Institute of Neuropsychiatric Care, Department of Child Psychiatry
City
Praha
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
GSC CHU-LENVAL Centre ressource autisme
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
6200
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent
City
Strasbourg
State/Province
Alsace-Champagne-Ardenne-Lorraine
ZIP/Postal Code
67091
Country
France
Facility Name
Centre d'Investigation Clinique de Lyon
City
Bron
State/Province
Auvergne Rhone Alpes
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211
City
Bron Cedex
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
69678
Country
France
Facility Name
Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75019
Country
France
Facility Name
CHU Rouen
City
Rouen
State/Province
Normandie
ZIP/Postal Code
76000
Country
France
Facility Name
Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme
City
Sotteville-lès-Rouen
State/Province
Normandie
ZIP/Postal Code
76301
Country
France
Facility Name
Hôpital des Enfants-Pellegrin
City
Bordeaux
State/Province
Nouvelle Aquitaine
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier Charles Perrens CRA Aquitaine
City
Bordeaux
State/Province
Nouvelle-Aquitaine
ZIP/Postal Code
33076
Country
France
Facility Name
Vadaskert Korhaz es Szakambulancia
City
Budapest
ZIP/Postal Code
1021
Country
Hungary
Facility Name
Servus Salvus Kft.
City
Budapest
ZIP/Postal Code
1026
Country
Hungary
Facility Name
Magyar Református Egyház Bethesda Gyermekkórháza
City
Budapest
ZIP/Postal Code
1143
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Gyorgy Albert Klinikai Kozpont Gyermekgyógyászati Klinika Gyermek es Ifjusagpszichiátriai o
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Neuro Riabilitazione/Psicopatologia dell'età evolutiva Istituto Scientifico Medea - Bosisio Parini
City
Bosisio Parini
State/Province
Lombardia
ZIP/Postal Code
23842
Country
Italy
Facility Name
U.O. di Neuropsichiatria Infantile Fondazione Istituto Neurologico Nazionale Casimiro Mondino Istituto di Ricovero e Cura a Carattere Scientifico
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza Ospedale Pediatrico-Microcitemico
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09131
Country
Italy
Facility Name
Programma Interdipartimentale "Autismo 0-90" A.O.U. Policlinico "Gaetano Martino"
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98125
Country
Italy
Facility Name
U.O.C. Psichiatria dello Sviluppo IRCCS Fondazione Stella Maris
City
Calambrone
State/Province
Toscana
ZIP/Postal Code
56128
Country
Italy
Facility Name
U.O. di Neuropsichiatria Infantile Azienda Ospedaliera Universitaria Senese
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
"Niepubliczny Zakład Opieki Zdrowotnej Gdańskie Centrum Zdrowia Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-542
Country
Poland
Facility Name
Centrum Badań Klinicznych PI-House sp. z o.o
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
NAVICULA Centrum Diagnozy i Terapii Autyzmu w Łodzi
City
Lodz
ZIP/Postal Code
91-126
Country
Poland
Facility Name
Fundacja SYNAPSIS ul.
City
Warszawa
ZIP/Postal Code
02-085
Country
Poland
Facility Name
Samodzielny Publiczny Dziecięcy Szpital Kliniczny w Warszawie Oddział Kliniczny Psychiatrii Wieku Rozwojowego
City
Warszawa
ZIP/Postal Code
02-091
Country
Poland
Facility Name
Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico
City
Coimbra
ZIP/Postal Code
300-062
Country
Portugal
Facility Name
National Institute of Children Diseases, Department of Child Psychiatry
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Facility Name
EPAMED, s.r.o.
City
Košice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Hospita Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Policlinica Guipuzcoa
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03007
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Niño Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Colchester Hospital
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
ReCognition Health
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
The Winnicott Centre 195-197 Hathersage Road
City
Manchester
ZIP/Postal Code
M13 0JE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing Access Criteria
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
IPD Sharing URL
https://clinicaltrials.servier.com/
Links:
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL3-95008-002-anonymisedsynopsis-2022.04.14.pdf
Description
Results summary
URL
http://clinicaltrials.servier.com/wp-content/uploads/CL3-95008-002-laysummary-2022.04.25.pdf
Description
Lay summary
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
study-level clinical trial data]
Available IPD/Information URL
https://clinicaltrials.servier.com/
Learn more about this trial
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
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