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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|ClinicalTrials.gov Identifier: NCT03715153|
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder (ASD)||Drug: BUMETANIDE/S95008 Drug: PLACEBO||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Actual Study Start Date :||October 4, 2018|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||April 2022|
Oral solution dosed at 0.5 mg/mL Taken twice daily.
|Placebo Comparator: PLACEBO||
Oral solution Taken twice daily.
- Childhood Autism Rating Scale, Second Edition (CARS2) total raw score [ Time Frame: 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.
- Social Responsiveness Scale, Second Edition (SRS-2) total raw score [ Time Frame: Change from baseline to 6 month ]Efficacy criterion 65 items scale measuring symptoms associated with autism
- Clinical Global Impression - Global Improvement (CGI-I) score [ Time Frame: At 6 months ]Efficacy criterion Scale which assesses the severity of the illness and the global improvement of the patient Under study treatment
- Vineland Adaptative Behaviour Scale II (VABS II) [ Time Frame: Change from baseline to 6 month ]Efficacy criterion Scale designated to measure adaptative behaviour
- Adverse Event and Pediatric Adverse Event Rating Scale (PAERS) [ Time Frame: On average of 52 weeks ]Safety criterion Inventory report used to identify signs/symptoms experienced by the patient since the study treatment initiation.
- Abnormalities in 12-leads electrocardiogram (ECG) parameters [ Time Frame: Selection visit, Week004, Week008, Week012, Week026, Week030, Week034, Week038, Week052 ]Safety criterion
- Renal ultrasound [ Time Frame: Selection visit, Week026, Week052 ]Safety criterion Assessment of the renal function
- Columbia-Suicide severity scale Children's version (C-SSRS-C) [ Time Frame: Week000/Week012/Week026/Week038/Week052 ]Scale which assesses suicidal ideation and suicidal behaviour
- Acceptability and palatability questionnaires [ Time Frame: Week026 ]Acceptability and palatability criterion Assessment of the ease of use to use the dosing device
- Paediatric Quality of Life Inventory (PedsQL) questionnaire [ Time Frame: Week000/Week004/Week012/v026/Week030/Week038/Week052 ]Quality of Life questionnaire Assessment of parent/legal representative perception of patient health related quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715153
|Contact: Institut de Recherches Internationales Servier Clinical Studies Department||+33 1 55 72 43 firstname.lastname@example.org|